io.github.medley/fda-data
FDA Data MCP
Clean FDA regulatory data: company resolution, facilities, recalls, inspections, approvals.
Status
Failing
Score
58.0
Transport
streamable-http
Tools
0
Production readiness
Verdict
Needs remediation
Current validation evidence shows operational or discovery gaps that should be fixed first.
Critical alerts
2
Production verdicts degrade quickly when critical alerts are active.
Evidence confidence
Confidence score
55.0
Based on 20 recent validations, 26 captured checks, and validation age of 65.6 hours.
Live checks captured
26
More direct checks increase trust in the current verdict.
Validation age
65.6h
Lower age means fresher evidence.
Recommended for
Generic Streamable HTTP
Generic Streamable HTTP is marked compatible with score 83.
Client readiness verdicts
Ready for ChatGPT custom connector
Partial
OpenAI connectors expect OAuth for remote server auth.; Dynamic client registration materially improves connector setup.; tools/list must succeed.
Confidence: medium (55.0)
Evidence provenance
Winner: live_validation
Supporting sources: live_validation, history, server_card
Disagreements: none
initialize• OKtools_list• Errortransport_compliance_probe• Warningstep_up_auth_probe• Missingconnector_replay_probe• Missing — Frozen tool snapshots must survive refresh.request_association_probe• Missing — Roots, sampling, and elicitation should stay request-scoped.
Ready for Claude remote MCP
Partial
tools/list must succeed.; A useful Claude integration needs at least one exposed tool.
Confidence: medium (55.0)
Evidence provenance
Winner: live_validation
Supporting sources: live_validation, history, server_card
Disagreements: none
initialize• OKtools_list• Errortransport_compliance_probe• Warning
Unsafe for write actions
No
Current write surface is bounded enough for cautious review.
Confidence: medium (55.0)
Evidence provenance
Winner: live_validation
Supporting sources: live_validation, history
Disagreements: none
action_safety_probe• OK
Snapshot churn risk
Low
No material tool-surface churn detected in the latest comparison.
Confidence: medium (55.0)
Evidence provenance
Winner: history
Supporting sources: history, live_validation
Disagreements: none
tool_snapshot_probe• Missingconnector_replay_probe• Missing
Why not ready by client
ChatGPT custom connector
Partial
Remediation checklist
- No explicit blockers recorded.
Claude remote MCP
Partial
Remediation checklist
- No explicit blockers recorded.
Write-safe publishing
Ready
Remediation checklist
- No explicit blockers recorded.
Verdict traces
Production verdict
Needs remediation
Current validation evidence shows operational or discovery gaps that should be fixed first.
Confidence: medium (55.0)
Winning source: live_validation
Triggering alerts
validation_stale• medium • Validation evidence is staleserver_failing• critical • Latest validation is failingauth_mode_changed• high • Auth mode changed
Client verdict trace table
| Verdict | Status | Checks | Winning source | Conflicts |
|---|---|---|---|---|
openai_connectors |
Partial | initialize, tools_list, transport_compliance_probe, step_up_auth_probe, connector_replay_probe, request_association_probe | live_validation | none |
claude_desktop |
Partial | initialize, tools_list, transport_compliance_probe | live_validation | none |
unsafe_for_write_actions |
No | action_safety_probe | live_validation | none |
snapshot_churn_risk |
Low | tool_snapshot_probe, connector_replay_probe | history | none |
Publishability policy profiles
ChatGPT custom connector publishability
Caution
OpenAI connectors expect OAuth for remote server auth.; Dynamic client registration materially improves connector setup.; tools/list must succeed.
- Search Fetch Only: No
- Write Actions Present: No
- Oauth Configured: No
- Admin Refresh Required: No
- Safe For Company Knowledge: No
- Safe For Messages Api Remote Mcp: No
Claude remote MCP publishability
Caution
tools/list must succeed.; A useful Claude integration needs at least one exposed tool.
- Search Fetch Only: No
- Write Actions Present: No
- Oauth Configured: No
- Admin Refresh Required: No
- Safe For Company Knowledge: No
- Safe For Messages Api Remote Mcp: No
Compatibility fixtures
ChatGPT custom connector fixture
Degraded
OpenAI connectors expect OAuth for remote server auth.; Dynamic client registration materially improves connector setup.; tools/list must succeed.
- remote_http_endpoint: Passes
- oauth_discovery: Degraded
- frozen_tool_snapshot_refresh: Passes
- request_association: Passes
Anthropic remote MCP fixture
Degraded
tools/list must succeed.; A useful Claude integration needs at least one exposed tool.
- remote_transport: Passes
- tool_discovery: Likely to fail
- auth_connect: Passes
- safe_write_review: Passes
Authenticated validation sessions
Latest profile
remote_mcp
Authenticated session used
Public score isolation
Preview endpoint
/v1/verifyCI preview endpoint
/v1/ci/previewPublic server reputation
Validation success 7d
0.0
Validation success 30d
0.0
Mean time to recover
n/a
Breaking diffs 30d
0
Registry drift frequency 30d
0
Snapshot changes 30d
0
Incident & change feed
| Timestamp | Event | Details |
|---|---|---|
| May 01, 2026 12:17:24 PM UTC | Latest validation: failing | Score 58.0 with status failing. |
| May 01, 2026 12:17:24 PM UTC | Score changed | Score delta +5.2 versus the previous run. |
| May 01, 2026 12:17:24 PM UTC | Auth mode changed | Auth mode moved from unknown to public. |
| Apr 30, 2026 04:16:43 PM UTC | Score changed | Score delta -5.3 versus the previous run. |
| Apr 30, 2026 04:16:43 PM UTC | Auth mode changed | Auth mode moved from public to unknown. |
Capabilities
- OAuth:
- DCR/CIMD:
- Prompts:
- Homepage: none
- Docs: none
- Support: none
- Icon: none
- Remote endpoint: https://www.regdatalab.com/mcp
- Server card: none
Use-case taxonomy
development
Security posture
Tools analyzed
0
High-risk tools
0
Destructive tools
0
Exec tools
0
Egress tools
0
Secret tools
0
Bulk-access tools
0
Risk distribution
none
Tool capability & risk inventory
No tool inventory available from the latest validation run.
Write-action governance
Governance status
OK
Safe to publish
Auth boundary
public_or_unclear
Blast radius
Low
High-risk tools
0
Confirmation signals
none
Safeguard count
0
Status detail: No unsafe write-action governance gaps detected on the latest validation.
| Tool | Risk | Flags | Safeguards |
|---|---|---|---|
| No high-risk tools were detected on the latest run. | |||
Action-controls diff
Need at least two validation runs before diffing action controls.
Why this score?
Access & Protocol
31.5/44
Connectivity, auth, and transport expectations for common clients.
Interface Quality
14.17/56
How well the tool/resource interface communicates and behaves under automation.
Security Posture
25/36
How safely the exposed tool surface handles destructive actions, egress, execution, secrets, and risky inputs.
Reliability & Trust
17.56/24
Operational stability, consistency, and trustworthiness over time.
Discovery & Governance
21.5/28
How well the server is documented, listed, and governed in public registries.
Adoption & Market
4/8
Adoption clues and public evidence that the server is intended for external use.
Algorithmic score breakdown
Auth Operability
2/4
Measures whether auth discovery and protected access behave predictably for clients.
Error Contract Quality
0.7/4
Grades machine-readable error structure, status alignment, and remediation hints.
Rate-Limit Semantics
2/4
Checks whether quota/throttle responses are deterministic and automation-friendly.
Schema Completeness
0/4
Completeness of tool descriptions, parameter docs, examples, and schema shape.
Backward Compatibility
4/4
Stability score across tool schema/name drift relative to prior validations.
SLO Health
2.7/4
Availability, latency, and burst-failure profile across recent validation history.
Security Hygiene
3/4
HTTPS posture, endpoint hygiene, and response-surface hardening checks.
Task Success
3.3/4
Can an agent reliably initialize, enumerate tools, and execute core MCP flows?
Trust Confidence
2/4
Confidence-adjusted reliability score that penalizes low evidence volume.
Abuse/Noise Resilience
2.5/4
How well the server preserves core behavior in the presence of noisy traffic patterns.
Prompt Contract
2/4
Quality of prompt metadata, argument shape, and prompt discoverability for clients.
Resource Contract
2/4
How completely resources and resource templates describe URIs, types, and usage shape.
Discovery Metadata
3/4
Homepage, docs, icon, repository, support, and license coverage for directory consumers.
Registry Consistency
3/4
Agreement between stored registry metadata, live server-card data, and current validation output.
Installability
2/4
How cleanly a real client can connect, initialize, enumerate tools, and proceed through auth.
Session Semantics
2.5/4
Determinism and state behavior across repeated MCP calls, including sticky-session surprises.
Tool Surface Design
0/4
Naming clarity, schema ergonomics, and parameter complexity across the tool surface.
Result Shape Stability
0/4
Stability of declared output schemas across validations, with penalties for drift or missing shapes.
OAuth Interop
3/4
Depth and client compatibility of OAuth/OIDC metadata beyond the minimal protected-resource check.
Recovery Semantics
0.5/4
Whether failures include actionable machine-readable next steps such as retry or upgrade guidance.
Maintenance Signal
3/4
Versioning, update recency, and historical validation cadence that indicate active stewardship.
Adoption Signal
2/4
Directory presence and distribution clues that suggest the server is intended for external use.
Freshness Confidence
3/4
Confidence that recent validations are current enough and dense enough to trust operationally.
Transport Fidelity
4/4
Whether declared transport metadata matches the observed endpoint behavior and response formats.
Spec Recency
2/4
How close the server’s claimed MCP protocol version is to the latest known public revision.
Session Resume
4/4
Whether Streamable HTTP session identifiers and resumed requests behave cleanly for real clients.
Step-Up Auth
3/4
Whether OAuth metadata and WWW-Authenticate challenges support granular, incremental consent instead of broad upfront scopes.
Transport Compliance
3/4
Checks session headers, protocol-version enforcement, session teardown, and expired-session behavior.
Utility Coverage
2/4
Signals support for completions, pagination, and task-oriented utility surfaces that larger clients increasingly expect.
Advanced Capability Coverage
2/4
Coverage of newer MCP surfaces like roots, sampling, elicitation, structured output, and related metadata.
Connector Publishability
2/4
How ready the server looks for client catalogs and managed connector programs.
Tool Snapshot Churn
0/4
Stability of the tool surface across recent validations, including add/remove and output-shape drift.
Connector Replay
3/4
Whether a previously published frozen connector snapshot would remain backward compatible after the latest tool refresh.
Request Association
3/4
Whether roots, sampling, and elicitation appear tied to active client requests instead of arriving unsolicited on idle sessions.
Interactive Flow Safety
3/4
Whether prompts and docs steer users toward safe auth flows instead of pasting secrets directly.
Action Safety
3/4
Risk-weighted view of destructive, exec, egress, and confirmation semantics across the tool surface.
Official Registry Presence
4/4
Whether the server appears directly or indirectly in the official MCP registry.
Provenance Divergence
4/4
How closely official registry metadata, the live server card, and public repo/package signals agree with each other.
Safety Transparency
2/4
Clarity of docs, auth disclosure, support links, and other trust signals visible to integrators.
Tool Capability Clarity
0/4
How clearly the tool surface communicates whether each action reads, writes, deletes, executes, or exports data.
Destructive Operation Safety
3/4
Penalizes delete/revoke/destroy style tools unless auth and safeguards reduce blast radius.
Egress / SSRF Resilience
3/4
Assesses arbitrary URL fetch, crawl, webhook, and remote-request exposure on the tool surface.
Execution / Sandbox Safety
4/4
Evaluates shell, code, script, and command-execution exposure and whether that surface appears contained.
Data Exfiltration Resilience
3/4
Assesses export, dump, backup, and bulk-read behavior against the surrounding auth and safeguard signals.
Least Privilege Scope
3/4
Rewards scoped auth metadata and penalizes broad or missing scopes around privileged tools.
Secret Handling Hygiene
3/4
Assesses secret-bearing tools, token leakage risk, and whether the public surface avoids obvious secret exposure.
Supply Chain Signal
2.5/4
Public metadata signal for repository, changelog, license, versioning, and recency that supports supply-chain trust.
Input Sanitization Safety
0/4
Penalizes risky freeform string inputs when schemas do not constrain URLs, code, paths, queries, or templates.
Tool Namespace Clarity
0/4
Measures naming uniqueness and ambiguity across the tool namespace to reduce collision and confusion risk.
Compatibility profiles
OpenAI Connectors
66.7
partial
OpenAI connectors expect OAuth for remote server auth.; Dynamic client registration materially improves connector setup.; tools/list must succeed.
Connector URL: https://www.regdatalab.com/mcp # No OAuth metadata detected. # Server: io.github.medley/fda-data
Claude Desktop
66.7
partial
tools/list must succeed.; A useful Claude integration needs at least one exposed tool.
{
"mcpServers": {
"fda-data": {
"command": "npx",
"args": ["mcp-remote", "https://www.regdatalab.com/mcp"]
}
}
}
Smithery
60.0
partial
Tool discovery must succeed.; Machine-readable failure semantics should be present.
smithery mcp add "https://www.regdatalab.com/mcp"
Generic Streamable HTTP
83.3
compatible
tools/list must succeed.
curl -sS https://www.regdatalab.com/mcp -H 'content-type: application/json' -d '{"jsonrpc":"2.0","id":1,"method":"initialize","params":{"protocolVersion":"2025-03-26","capabilities":{},"clientInfo":{"name":"mcp-verify","version":"0.1.0"}}}'
Actionable remediation
| Severity | Remediation | Why it matters | Recommended action |
|---|---|---|---|
| Critical | Ensure tools/list succeeds consistently | Tools discovery is the minimum viable contract for most MCP clients and directories. | Make tools/list succeed unauthenticated when possible, or document the auth flow in the server card.Playbook
|
| Critical | Respond to latest validation is failing | Core MCP flows did not validate successfully on the latest run. | Fix the failing checks first, then revalidate to confirm the recovery path.Playbook
|
| High | Align session and protocol behavior with Streamable HTTP expectations | Clients increasingly rely on MCP-Protocol-Version, session teardown, and expired-session semantics. | Align MCP-Protocol-Version, MCP-Session-Id, DELETE teardown, and expired-session handling with the transport spec.Playbook
|
| High | Associate roots, sampling, and elicitation with active client requests | Modern MCP guidance expects roots, sampling, and elicitation traffic to be tied to an active client request instead of arriving unsolicited on idle sessions. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
| High | Expose /.well-known/oauth-protected-resource | Without a protected-resource document, OAuth clients cannot discover auth requirements reliably. | Serve /.well-known/oauth-protected-resource and point it at your authorization server metadata.Playbook
|
| High | Keep connector refreshes backward compatible | Managed connector clients freeze tool snapshots, so removed tools, new required args, and breaking output changes can break published integrations after refresh. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
| High | Publish OAuth authorization-server metadata | Clients need authorization-server metadata to discover issuer, endpoints, and DCR support. | Publish /.well-known/oauth-authorization-server from your issuer and include registration_endpoint when supported.Playbook
|
| High | Respond to auth mode changed | Auth mode changed from unknown to public. | Document the new auth posture and confirm protected-resource and challenge metadata still match reality.Playbook
|
| High | Stop asking users to paste secrets directly | Public MCP servers should prefer OAuth or browser-based auth guidance over in-band secret collection. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
| Medium | Adopt a current MCP protocol revision | Older protocol revisions reduce compatibility with newer clients and registry programs. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
| Medium | Close connector-publishing gaps | Connector catalogs care about protocol recency, session behavior, auth clarity, and tool-surface stability. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
| Medium | Document minimal scopes and return cleaner auth challenges | Modern clients expect granular scopes and step-up auth signals such as WWW-Authenticate scope hints. | Return granular scopes and WWW-Authenticate challenge hints instead of forcing overly broad auth upfront.Playbook
|
| Medium | Publish OpenID configuration | OIDC metadata improves token validation and client compatibility. | Expose /.well-known/openid-configuration with issuer, jwks_uri, and supported grants.Playbook
|
| Medium | Raise Adoption & Market score | Adoption clues and public evidence that the server is intended for external use. | Increase external documentation and directory coverage so users can discover and evaluate the server.Playbook
|
| Medium | Raise Interface Quality score | How well the tool/resource interface communicates and behaves under automation. | Improve schemas, error contracts, and recovery messages so agents can reason about the surface automatically.Playbook
|
| Medium | Reduce tool-surface churn | Frequent add/remove or output-shape drift makes published connectors and cached tool snapshots brittle. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
| Medium | Repair prompts/list or stop advertising prompts | Prompt metadata should either work live or be removed from the advertised capability set. | Only advertise prompts if prompts/list works and prompt arguments are documented.Playbook
|
| Medium | Repair resources/list or stop advertising resources | Resource metadata should either work live or be removed from the advertised capability set. | Only advertise resources if resources/list works and resources expose stable URIs/types.Playbook
|
| Medium | Respond to validation evidence is stale | Latest validation is 65.6 hours old. | Trigger a fresh validation run or increase scheduler priority for this server.Playbook
|
| Low | Expose modern utility surfaces like completions, pagination, or tasks | Utility coverage improves interoperability with larger clients and long-lived agent workflows. | Expose completions, pagination, and task metadata where supported so larger clients can plan and resume work safely.Playbook
|
| Low | Publish newer MCP capability signals | Roots, sampling, elicitation, structured outputs, and related metadata improve client understanding and ranking. | Inspect the latest validation evidence and resolve the client-visible regression.Playbook
|
Point loss breakdown
| Component | Current | Points missing |
|---|---|---|
| Tool Surface Design | 0/4 | -4.0 |
| Tool Snapshot Churn | 0/4 | -4.0 |
| Tool Namespace Clarity | 0/4 | -4.0 |
| Tool Capability Clarity | 0/4 | -4.0 |
| Schema Completeness | 0/4 | -4.0 |
| Result Shape Stability | 0/4 | -4.0 |
| Input Sanitization Safety | 0/4 | -4.0 |
| Recovery Semantics | 0.5/4 | -3.5 |
| Error Contract | 0.7/4 | -3.3 |
| Utility Coverage | 2/4 | -2.0 |
| Trust Confidence | 2/4 | -2.0 |
| Spec Recency | 2/4 | -2.0 |
Validation diff
Score delta
5.16
Summary changed
no
Tool delta
0
Prompt delta
0
Auth mode changed
yes
Write surface expanded
no
Protocol regressed
no
Registry drift changed
no
Regressed checks: none
Improved checks: initialize, session_resume_probe
| Component | Previous | Latest | Delta |
|---|---|---|---|
oauth_interop_score | 3.0 | 3.0 | |
session_semantics_score | 2.5 | 2.5 | |
auth_operability_score | 2.0 | 2.0 | |
safety_transparency_score | 4.0 | 2.0 | -2.0 |
task_success_score | 1.67 | 3.33 | 1.66 |
installability_score | 3.31 | 2.0 | -1.31 |
connector_publishability_score | 3.15 | 2.0 | -1.15 |
least_privilege_scope_score | 2.0 | 3.0 | 1.0 |
Tool snapshot diff & changelog
Need at least two validation runs before building a tool changelog.
Connector replay
Status
Missing
Backward compatible
Would break after refresh
Added tools
none
Removed tools
none
Additive output changes
none
Required-argument replay breaks
| Tool | Added required args | Removed required args |
|---|---|---|
| No required-argument replay breaks detected. | ||
Output-schema replay breaks
| Tool | Removed properties | Added properties |
|---|---|---|
| No output-schema replay breaks detected. | ||
Transport compliance drilldown
Probe status
Warning
Transport
streamable-http
Session header
yes
Protocol header
no
Bad protocol response
400
DELETE teardown
200
Expired session retry
404
Last-Event-ID visible
no
Issues: missing_protocol_header
Request association
Status
Missing
Advertised capabilities
none
Observed idle methods
none
Violating methods
none
Probe HTTP status
n/a
Issues
none
Utility coverage
Probe status
Missing
Completions
not detected
Completion probe target: none
Pagination
not detected
No nextCursor evidence.
Tasks
Missing
Advertised: no
Benchmark tasks
| Benchmark task | Status | Evidence |
|---|---|---|
| Discover tools | Likely to fail |
|
| Read-only fetch flow | Likely to fail |
|
| OAuth-required connect | Degraded |
|
| Safe write flow with confirmation | Passes |
|
Registry & provenance divergence
Probe status
OK
Direct official match
yes
Drift fields
none
| Field | Registry | Live server card |
|---|---|---|
| Title | n/a | FDA Data MCP |
| Version | n/a | n/a |
| Homepage | n/a | n/a |
Active alerts
- Validation evidence is stale (medium)
Latest validation is 65.6 hours old. - Latest validation is failing (critical)
Core MCP flows did not validate successfully on the latest run. - Auth mode changed (high)
Auth mode changed from unknown to public.
Aliases & registry graph
| Identifier | Source | Canonical | Score |
|---|---|---|---|
io.github.medley/fda-data |
official_registry | yes | 58.03 |
Alias consolidation
Canonical identifier
io.github.medley/fda-data
Duplicate aliases
0
Registry sources
official_registry
Remote URLs
Homepages
none
Source disagreements
| Field | What differs | Observed values |
|---|---|---|
| No source disagreements detected. | ||
Install snippets
Openai Connectors
Connector URL: https://www.regdatalab.com/mcp # No OAuth metadata detected. # Server: io.github.medley/fda-data
Claude Desktop
{
"mcpServers": {
"fda-data": {
"command": "npx",
"args": ["mcp-remote", "https://www.regdatalab.com/mcp"]
}
}
}
Smithery
smithery mcp add "https://www.regdatalab.com/mcp"
Generic Http
curl -sS https://www.regdatalab.com/mcp -H 'content-type: application/json' -d '{"jsonrpc":"2.0","id":1,"method":"initialize","params":{"protocolVersion":"2025-03-26","capabilities":{},"clientInfo":{"name":"mcp-verify","version":"0.1.0"}}}'
Agent access & tool surface
Live server tools
No live tool surface captured yet.
Observed from the latest live validation against https://www.regdatalab.com/mcp. This is the target server surface, not Verify's own inspection tools.
Live capability counts
0 tools • 0 prompts • 0 resources
Counts come from the latest
tools/list, prompts/list, and resources/list checks.Inspect with Verify
search_servers recommend_servers get_server_report compare_servers
Use Verify itself to search, recommend, compare, and fetch the full report for
io.github.medley/fda-data.Direct machine links
Claims & monitoring
Server ownership
No verified maintainer claim recorded.
Watch subscriptions
0
Teams: none
Alert routing
Active watches
0
Generic webhooks
0
Slack routes
0
Teams routes
0
Email routes
0
| Watch | Team | Channels | Minimum severity |
|---|---|---|---|
| No active watch destinations. | |||
Maintainer analytics
Validation Run Count
20
Average Latency Ms
1813.41
Healthy Run Ratio Recent
0.0
Registry Presence Count
1
Active Alert Count
3
Watcher Count
0
Verified Claim
False
Taxonomy Tags
development
Score Trend
58.03, 52.87, 58.16, 58.16, 58.16, 58.16, 58.16, 58.16, 58.16, 58.16
Remediation Count
21
High Risk Tool Count
0
Destructive Tool Count
0
Exec Tool Count
0
Maintainer response quality
Score
16.67
Verified claim
Support contact
Changelog present
Incident notes present
Tool changes documented
Annotation history
Annotation count
0
Maintainer annotations
No maintainer annotations have been recorded yet.
Maintainer rebuttals & expected behavior
No maintainer rebuttals or expected-behavior overrides are recorded yet.
Latest validation evidence
Latest summary
Failing
Validation profile
remote_mcp
Started
May 01, 2026 12:17:22 PM UTC
Latency
1640.8 ms
Failures
oauth_authorization_serverno authorization serveroauth_protected_resourceClient error '404 Not Found' for url 'https://www.regdatalab.com/.well-known/oauth-protected-resource' For more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/404openid_configurationno authorization servertools_listClient error '400 Bad Request' for url 'https://www.regdatalab.com/mcp' For more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/400
Checks
| Check | Status | Latency | Evidence |
|---|---|---|---|
action_safety_probe |
OK | n/a | No high-risk write, destructive, or exec tools detected. |
advanced_capabilities_probe |
Missing | n/a | No advanced MCP capability signals detected. |
connector_publishability_probe |
Error | n/a | Publishability blockers: tools list, tool surface. |
connector_replay_probe |
Missing | n/a | No connector replay evidence recorded. |
determinism_probe |
Missing | n/a | tools list unavailable |
initialize |
OK | 88.3 ms | Protocol 2025-03-26 |
interactive_flow_probe |
Missing | n/a | Check completed |
oauth_authorization_server |
Missing | n/a | no authorization server |
oauth_protected_resource |
Error | 28.2 ms | Client error '404 Not Found' for url 'https://www.regdatalab.com/.well-known/oauth-protected-resource' For more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/404 |
official_registry_probe |
OK | n/a | Check completed |
openid_configuration |
Missing | n/a | no authorization server |
probe_noise_resilience |
OK | 25.8 ms | Fetched https://www.regdatalab.com/robots.txt |
prompt_get |
Missing | n/a | not advertised |
prompts_list |
Missing | 37.3 ms | Client error '400 Bad Request' for url 'https://www.regdatalab.com/mcp' For more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/400 |
protocol_version_probe |
Warning | n/a | Claims 2025-03-26; 2 release(s) behind 2025-11-25. |
provenance_divergence_probe |
OK | n/a | Check completed |
request_association_probe |
Missing | n/a | No request-association capabilities were advertised. |
resource_read |
Missing | n/a | not advertised |
resources_list |
Missing | 30.6 ms | Client error '400 Bad Request' for url 'https://www.regdatalab.com/mcp' For more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/400 |
server_card |
OK | 1044.0 ms | auth, description, name, server_url |
session_resume_probe |
OK | 32.1 ms | 48 tool(s) exposed |
step_up_auth_probe |
Missing | n/a | No OAuth or incremental-scope signals detected. |
tool_snapshot_probe |
Missing | n/a | no tools |
tools_list |
Error | 29.6 ms | Client error '400 Bad Request' for url 'https://www.regdatalab.com/mcp' For more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/400 |
transport_compliance_probe |
Warning | 29.1 ms | Issues: missing protocol header (bad protocol=400, DELETE=200, expired session=404). |
utility_coverage_probe |
Missing | 9.8 ms | No completions evidence; no pagination evidence; tasks missing. |
Raw evidence view
Show raw JSON evidence
{
"checks": {
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"summary": {
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}
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"advanced_capabilities_probe": {
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},
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"connector_publishability_probe": {
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],
"criteria": {
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"initialize": true,
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"transport_compliance": true
},
"high_risk_tools": 0,
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"transport": "streamable-http"
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"initialize": {
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"payload": {
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"tools": {
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},
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"details": {
"error": "Client error '404 Not Found' for url 'https://www.regdatalab.com/.well-known/oauth-protected-resource'\nFor more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/404",
"url": "https://www.regdatalab.com/.well-known/oauth-protected-resource"
},
"latency_ms": 28.19,
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},
"probe_noise_resilience": {
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},
"http_status": 200,
"url": "https://www.regdatalab.com/robots.txt"
},
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},
"prompt_get": {
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"headers": {
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},
"latency_ms": 37.34,
"status": "missing"
},
"protocol_version_probe": {
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},
"latency_ms": null,
"status": "warning"
},
"provenance_divergence_probe": {
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"headers": {
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"strict-transport-security": "max-age=31536000; includeSubDomains"
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"url": "https://www.regdatalab.com/mcp"
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"status": "missing"
},
"server_card": {
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"headers": {
"content-type": "application/json; charset=utf-8",
"strict-transport-security": "max-age=31536000; includeSubDomains"
},
"http_status": 200,
"payload": {
"auth": {
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"required_for_tool_calls": true,
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},
"description": "Manufacturing-first FDA intelligence for Claude Desktop, Cowork, and other MCP clients.",
"name": "FDA Data MCP",
"server_url": "https://www.regdatalab.com/mcp",
"signup_url": "https://www.regdatalab.com/signup",
"wrapper": {
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}
},
"url": "https://www.regdatalab.com/.well-known/mcp/server-card.json"
},
"latency_ms": 1043.95,
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},
"session_resume_probe": {
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"strict-transport-security": "max-age=31536000; includeSubDomains"
},
"http_status": 200,
"payload": {
"id": 301,
"jsonrpc": "2.0",
"result": {
"tools": [
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Quick company lookup: facilities (with addresses and operations) and enforcement actions (recalls) for a single company and its known aliases. Costs 1 credit. Excludes: 510(k) clearances, PMA approvals, drug applications, inspection history, and subsidiary data. Related: fda_company_full (adds clearances/approvals/drugs for 5 credits), fda_suggest_subsidiaries (discover related entities), fda_get_facility (per-facility products and operations by FEI).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company": {
"description": "Company name to look up",
"maxLength": 500,
"type": "string"
},
"enforcement_limit": {
"default": 200,
"description": "Enforcement result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"enforcement_offset": {
"default": 0,
"description": "Enforcement result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"facilities_limit": {
"default": 200,
"description": "Facilities result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"facilities_offset": {
"default": 0,
"description": "Facilities result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_lookup_company",
"title": "Company Lookup"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA-registered facilities by name, city, state, or country. Searches drug (DECRS) and device registration databases. Returns FEI number, name, address, and source. Use the operations parameter to filter by manufacturing type (e.g., 'Contract Manufacture', 'API', 'Repack'). Use country filter (ISO code: US, DE, IN, CN, IE) to map a company's global manufacturing footprint. Excludes: products at facility, inspection history, enforcement actions. Related: fda_get_facility (full facility detail by FEI including products and operations type), fda_inspections (inspection data by FEI), fda_citations (CFR violations by FEI).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"city": {
"description": "City name",
"maxLength": 500,
"type": "string"
},
"company": {
"description": "Facility or company name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"country": {
"description": "ISO country code (e.g. US, DE)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"operations": {
"description": "DECRS operations keyword",
"maxLength": 500,
"type": "string"
},
"state": {
"description": "State code (e.g. CA, NY)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_facilities",
"title": "Search Facilities"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA-registered facilities across a parent company and any explicitly linked subsidiaries. Use this when you know the parent company but the FDA records may sit under child entities like Actavis, Watson, or Cephalon. Supports optional city, state, country, and operations filters.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"city": {
"description": "City name",
"maxLength": 500,
"type": "string"
},
"company": {
"description": "Parent company name",
"maxLength": 500,
"type": "string"
},
"country": {
"description": "ISO country code (e.g. US, DE)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"operations": {
"description": "DECRS operations keyword",
"maxLength": 500,
"type": "string"
},
"state": {
"description": "State code (e.g. CA, NY)",
"maxLength": 500,
"type": "string"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_search_family_facilities",
"title": "Search Family Facilities"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Detailed facility profile by FEI number. Returns: facility name, full address, operations type (Manufacture, API, Repack, Contract Manufacture, etc.), establishment types (Manufacturer, Distributor, Specification Developer, etc.), registrant and owner/operator info, DUNS number, registration expiry, enforcement history (recalls), device products with classification, and a facility_risk_summary (inspection counts by classification, warning letters, last inspection date). Requires: FEI number \u2014 get it from fda_search_facilities or fda_company_full. Excludes: full inspection details and citations. Related: fda_inspections (inspection history by FEI), fda_citations (CFR violations by FEI), fda_compliance_actions (warning letters/seizures by FEI), fda_import_refusals (import refusal history by FEI), fda_facility_products (paginate large product lists).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"fei": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"products_limit": {
"default": 200,
"description": "Products result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"products_offset": {
"default": 0,
"description": "Products result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"required": [
"fei"
],
"type": "object"
},
"name": "fda_get_facility",
"title": "Facility Detail"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Compliance-first facility dossier by FEI number. Returns the facility profile plus recent inspections, citations, warning letters, import refusal history, import-alert mentions, recall context, freshness, and recommended next tools. Use this when you want the fastest FEI-level manufacturing risk view instead of the broader product-focused facility profile.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"evidence_limit": {
"default": 5,
"description": "Number of recent evidence rows to return per evidence section",
"maximum": 20,
"minimum": 1,
"type": "integer"
},
"fei": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
}
},
"required": [
"fei"
],
"type": "object"
},
"name": "fda_facility_dossier",
"title": "Facility Compliance Dossier"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "List device products registered at a facility by FEI number with pagination. Returns product code, proprietary name, listing number, and classification details (device name, class, medical specialty). Note: fda_get_facility already includes products \u2014 use this only when paginating through large product lists. Drug products are not linked by FEI; use fda_search_ndc with company name instead. Requires: FEI number.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"fei": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"required": [
"fei"
],
"type": "object"
},
"name": "fda_facility_products",
"title": "Facility Products"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA enforcement actions (recalls) for drugs, devices, and food across all companies. Filter by company name (fuzzy match), recall classification (Class I=most serious/Class II/Class III), date range, or status (Ongoing/Terminated). Returns recall details including product description, reason, and distribution pattern. Related: fda_recall_facility_trace (trace a recall to its manufacturing facility by recall_number), fda_ires_enforcement (iRES recall data with cross-references), fda_device_recalls (device-specific recall data).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"classification": {
"description": "Recall classification severity",
"enum": [
"Class I",
"Class II",
"Class III"
],
"type": "string"
},
"company": {
"description": "Company or firm name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"from_date": {
"description": "Start date for report_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"status": {
"description": "Recall status",
"enum": [
"Ongoing",
"Terminated"
],
"type": "string"
},
"to_date": {
"description": "End date for report_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_enforcement",
"title": "Search Recalls"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Full-text search across recall reasons and product descriptions using PostgreSQL text search. Finds recalls mentioning specific terms (e.g. 'salmonella contamination', 'mislabeled', 'sterility'). Supports multi-word queries ranked by relevance. Filter by classification, product_type, or date range. Related: fda_search_enforcement (search by company name, classification, status), fda_recall_facility_trace (trace a recall to its manufacturing facility).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"classification": {
"description": "Filter by recall classification severity",
"enum": [
"Class I",
"Class II",
"Class III"
],
"type": "string"
},
"date_from": {
"description": "Start date for report_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for report_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_type": {
"description": "Filter by product type",
"enum": [
"Drugs",
"Devices"
],
"type": "string"
},
"query": {
"description": "Search terms (e.g. 'salmonella contamination', 'mislabeled dosage')",
"maxLength": 500,
"minLength": 1,
"type": "string"
},
"search_field": {
"default": "both",
"description": "Which field to search: reason_for_recall, product_description, or both (default: both)",
"enum": [
"reason",
"product",
"both"
],
"type": "string"
}
},
"required": [
"query"
],
"type": "object"
},
"name": "fda_search_recall_text",
"title": "Full-Text Search Recalls"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Resolve a company name to its canonical company_id and list all known aliases. Returns the canonical slug, match confidence, and alias names. Read-only lookup \u2014 does not discover new aliases. Related: fda_suggest_subsidiaries (discover potential subsidiaries not yet aliased), fda_company_full (full profile using the resolved name).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company": {
"description": "Company name to resolve",
"maxLength": 500,
"type": "string"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_resolve_company",
"title": "Resolve Company Name"
},
{
"annotations": {
"destructiveHint": false,
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": false
},
"description": "Save normalized alias names for a parent company, updating confidence and tracking collisions. Use this for true name variants of the same company record. If a collision says the alias already belongs to another company_id, use fda_link_subsidiaries instead of forcing the alias. Typical workflow: call fda_suggest_subsidiaries first, review results, then call this tool with confirmed same-entity alias names.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"aliases": {
"description": "Alias entries to save",
"items": {
"properties": {
"alias": {
"description": "Alias name to associate with the company",
"maxLength": 500,
"type": "string"
},
"confidence": {
"description": "Alias confidence between 0 and 1",
"maximum": 1,
"minimum": 0,
"type": "number"
},
"source": {
"description": "Alias source identifier",
"maxLength": 500,
"type": "string"
}
},
"required": [
"alias"
],
"type": "object"
},
"maxItems": 100,
"minItems": 1,
"type": "array"
},
"parent_company": {
"description": "Canonical parent company name",
"maxLength": 500,
"type": "string"
}
},
"required": [
"parent_company",
"aliases"
],
"type": "object"
},
"name": "fda_save_aliases",
"title": "Save Company Aliases"
},
{
"annotations": {
"destructiveHint": false,
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": false
},
"description": "Explicitly link existing company records under a parent company for family-level rollups. Use this when names like Actavis or Cephalon already belong to their own company_id and should roll up under a parent like Teva. This preserves alias collision safety while making manufacturing and facility summaries family-aware.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"parent_company": {
"description": "Parent company that should own the family rollup",
"maxLength": 500,
"type": "string"
},
"subsidiaries": {
"description": "Subsidiary company records to link",
"items": {
"properties": {
"company": {
"description": "Existing company name to link under the parent",
"maxLength": 500,
"type": "string"
},
"confidence": {
"description": "Relationship confidence between 0 and 1",
"maximum": 1,
"minimum": 0,
"type": "number"
},
"notes": {
"description": "Optional notes about the relationship",
"maxLength": 2000,
"type": "string"
},
"source": {
"description": "Relationship source identifier",
"maxLength": 500,
"type": "string"
}
},
"required": [
"company"
],
"type": "object"
},
"maxItems": 100,
"minItems": 1,
"type": "array"
}
},
"required": [
"parent_company",
"subsidiaries"
],
"type": "object"
},
"name": "fda_link_subsidiaries",
"title": "Link Subsidiaries"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": true,
"readOnlyHint": true
},
"description": "Discover subsidiary and related company names using FDA datasets first, then supplement with external corporate hierarchy sources (SEC EDGAR Exhibit 21 and GLEIF) when available. Costs 2 credits. Returns FDA name candidates, evidence-backed company-record suggestions, EDGAR subsidiaries, GLEIF subsidiaries, existing aliases, and facility coverage stats. The coverage.unlinked_feis count indicates how many facilities may be missing from the current alias set. The workflow is conservative and explainable: it validates candidates against FDA company records instead of auto-linking them. Note: EDGAR and GLEIF may lag recent acquisitions or divestitures, so missing external results do not rule out FDA-visible subsidiaries. Recommended workflow: 1. fda_suggest_subsidiaries, 2. fda_link_subsidiaries for distinct child companies or fda_save_aliases for true same-company variants, 3. fda_manufacturing_risk_summary or fda_search_family_facilities. Related: fda_link_subsidiaries (persist explicit family links), fda_save_aliases (persist same-entity names), fda_manufacturing_risk_summary (family-aware company rollup), fda_search_family_facilities (family-aware FEI search).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"cik": {
"description": "SEC CIK (optional, auto-resolved if omitted)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"company": {
"description": "Company name to analyze",
"maxLength": 500,
"type": "string"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_suggest_subsidiaries",
"title": "Discover Subsidiaries"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Build a manufacturing and compliance summary for one company using FDA facilities, inspections, warning letters, OII records, import-risk signals, debarments, and recalls. Use this when you want the company-level picture first, then follow the linked granular tools for deeper inspection.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company": {
"description": "Company name to summarize",
"maxLength": 500,
"type": "string"
},
"evidence_limit": {
"default": 5,
"description": "Max recent records to return per evidence section",
"maximum": 25,
"minimum": 1,
"type": "integer"
},
"facility_limit": {
"default": 10,
"description": "Max facilities to return",
"maximum": 50,
"minimum": 1,
"type": "integer"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_manufacturing_risk_summary",
"title": "Manufacturing Risk Summary"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Build a reverse-chronological compliance timeline for one company and any linked subsidiaries. Combines inspections, warning letters, import alerts, import refusals, debarments, and recall/enforcement events into one dated feed.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company": {
"description": "Company name to build the timeline for",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 25,
"description": "Maximum number of combined timeline events to return",
"maximum": 100,
"minimum": 1,
"type": "integer"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_company_compliance_timeline",
"title": "Company Compliance Timeline"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search APHIS veterinary biologics establishments (animal health facilities) by company, state, or establishment type. Returns license number, company name, full address, establishment type (Licensee/Permittee), divisions, and subsidiaries. Covers vaccine manufacturers, diagnostic kit producers, and other veterinary biological product facilities. Related: fda_vet_events (veterinary adverse events by species/drug).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company": {
"description": "Company name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"state": {
"description": "State code (e.g., CA, NY)",
"maxLength": 10,
"type": "string"
},
"type": {
"description": "Establishment type",
"enum": [
"Licensee",
"Permittee"
],
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_aphis",
"title": "Search APHIS Vet Biologics"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA 510(k) clearances across all companies. Filter by company name (fuzzy match), product code, decision code (e.g., SESE=substantially equivalent), clearance type (Traditional, Special, Abbreviated), and date range. Returns clearance number (K-number), applicant, device name, decision date, and product code. Related: fda_device_class (product code details and classification), fda_product_code_lookup (cross-reference a product code across 510(k) and PMA), fda_search_pma (PMA approvals for higher-risk devices).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"clearance_type": {
"description": "Clearance type (e.g., Traditional, Special)",
"maxLength": 500,
"type": "string"
},
"company": {
"description": "Company name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"decision_code": {
"description": "Decision code (e.g., SESE, SESD)",
"maxLength": 500,
"type": "string"
},
"from_date": {
"description": "Start date for decision_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_code": {
"description": "Device product code",
"maxLength": 5,
"pattern": "^[A-Z]{2,3}$",
"type": "string"
},
"to_date": {
"description": "End date for decision_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_510k",
"title": "Search 510(k) Clearances"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA Pre-Market Approval (PMA) records across all companies. PMA is required for high-risk (Class III) devices. Filter by company name (fuzzy match), product code, and date range. Returns PMA number, applicant, trade name, decision date, and product code. Related: fda_device_class (product code details), fda_search_510k (510(k) clearances for lower-risk devices), fda_product_code_lookup (cross-reference a product code).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company": {
"description": "Company name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"from_date": {
"description": "Start date for decision_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_code": {
"description": "Device product code",
"maxLength": 5,
"pattern": "^[A-Z]{2,3}$",
"type": "string"
},
"to_date": {
"description": "End date for decision_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_pma",
"title": "Search PMA Approvals"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Lookup FDA device classification details by product code. Returns device name, device class (I/II/III), medical specialty, regulation number, review panel, submission type, and definition. Requires: product code (3-letter code from 510(k), PMA, or device product listings). Related: fda_product_code_lookup (cross-reference across 510(k) and PMA), fda_search_510k (clearances for this product code), fda_search_pma (PMA approvals for this product code).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"product_code": {
"description": "Device product code",
"maxLength": 5,
"pattern": "^[A-Z]{2,3}$",
"type": "string"
}
},
"required": [
"product_code"
],
"type": "object"
},
"name": "fda_device_class",
"title": "Device Classification Lookup"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Cross-reference a device product code across classification details, 510(k) clearances, and PMA approvals. Returns classification info plus paginated lists of all clearances and approvals for that product code. Use to understand the regulatory landscape for a specific device type. Requires: product code.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"approvals_limit": {
"default": 100,
"description": "PMA approvals result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"approvals_offset": {
"default": 0,
"description": "PMA approvals result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"clearances_limit": {
"default": 100,
"description": "510(k) clearances result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"clearances_offset": {
"default": 0,
"description": "510(k) clearances result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_code": {
"description": "Device product code",
"maxLength": 5,
"pattern": "^[A-Z]{2,3}$",
"type": "string"
}
},
"required": [
"product_code"
],
"type": "object"
},
"name": "fda_product_code_lookup",
"title": "Product Code Cross-Reference"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search Drugs@FDA applications across all companies. Filter by sponsor name (fuzzy match), application number, brand name, or submission status. Returns application details including products (brand names, dosage forms, active ingredients) and submissions (approval dates, status). Related: fda_search_ndc (NDC-level product details including labeler and packaging), fda_drug_labels (structured product labeling/package inserts), fda_clinical_result_letters (Complete Response Letters \u2014 FDA refusal-to-approve decisions), fda_drug_shortages (active drug shortage data).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"application_number": {
"description": "Application number",
"maxLength": 500,
"type": "string"
},
"brand_name": {
"description": "Brand name (searches products JSONB)",
"maxLength": 500,
"type": "string"
},
"company": {
"description": "Company name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"status": {
"description": "Submission status (searches submissions JSONB)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_drugs",
"title": "Search Drug Applications"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search the National Drug Code (NDC) directory by labeler company, brand name, product NDC, or application number. Returns labeler name, brand name, generic name, dosage form, route, active ingredients, DEA schedule, listing type, and packaging details. Drug products are not linked by FEI; use this tool with company name to find drugs at a company. Related: fda_search_drugs (application-level data with submissions), fda_drug_labels (full product labeling), fda_search_nsde (NSDE cross-reference).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"application_number": {
"description": "Application number",
"maxLength": 500,
"type": "string"
},
"brand_name": {
"description": "Brand name",
"maxLength": 500,
"type": "string"
},
"company": {
"description": "Labeler company name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_ndc": {
"description": "Product NDC",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_ndc",
"title": "Search NDC Directory"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search across FDA device and drug datasets by product name (device name, trade name, generic name, or brand name). Searches device classifications, 510(k) clearances, PMA approvals, and NDC records simultaneously. Use when you know a product name but not which dataset it's in. Returns matches from each dataset with product codes and company names.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_name": {
"description": "Product or brand name (fuzzy search)",
"maxLength": 500,
"type": "string"
}
},
"required": [
"product_name"
],
"type": "object"
},
"name": "fda_search_by_product",
"title": "Search by Product Name"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Trace a recall to its candidate manufacturing facility with explicit confidence levels. Matches by firm name, NDC lookup, and facility registration data. Returns the recall details, matched facility candidates with FEI numbers and confidence scores, and match methodology. Requires: recall_number from fda_search_enforcement or fda_ires_enforcement. Related: fda_get_facility (full detail for matched FEI), fda_inspections (inspection history for matched FEI), fda_compliance_actions (warning letters for matched FEI).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"recall_number": {
"description": "Recall number",
"maxLength": 500,
"type": "string"
}
},
"required": [
"recall_number"
],
"type": "object"
},
"name": "fda_recall_facility_trace",
"title": "Recall-to-Facility Trace"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Comprehensive company profile: facilities (with addresses and operations), enforcement actions (recalls), 510(k) clearances, PMA approvals, and drug applications for a single company and its known aliases. Costs 5 credits. Excludes: inspection history, citations, compliance actions (warning letters), facility-level product lists, import refusals, and family rollups across separate child company records. For family rollups: call fda_suggest_subsidiaries first, then use fda_save_aliases for true same-company names or fda_link_subsidiaries for distinct child companies. Related: fda_suggest_subsidiaries (discover subsidiaries), fda_link_subsidiaries (create explicit family links), fda_get_facility (per-facility products, operations type, risk summary by FEI), fda_inspections (inspection history by FEI or company), fda_citations (CFR violations by FEI), fda_compliance_actions (warning letters/seizures by FEI or company), fda_search_aphis (animal health facilities for vet companies), fda_drug_shortages (active drug shortages).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"approvals_limit": {
"default": 50,
"description": "PMA approvals result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"approvals_offset": {
"default": 0,
"description": "PMA approvals result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"clearances_limit": {
"default": 50,
"description": "510(k) clearances result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"clearances_offset": {
"default": 0,
"description": "510(k) clearances result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"company": {
"description": "Company name to look up",
"maxLength": 500,
"type": "string"
},
"drugs_limit": {
"default": 50,
"description": "Drug applications result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"drugs_offset": {
"default": 0,
"description": "Drug applications result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"enforcement_limit": {
"default": 50,
"description": "Enforcement result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"enforcement_offset": {
"default": 0,
"description": "Enforcement result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"facilities_limit": {
"default": 50,
"description": "Facilities result limit",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"facilities_offset": {
"default": 0,
"description": "Facilities result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"required": [
"company"
],
"type": "object"
},
"name": "fda_company_full",
"title": "Full Company Profile"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA inspection history from the Compliance Dashboard (not available in openFDA API). Filter by company name (fuzzy match), FEI number, classification (NAI=No Action Indicated, VAI=Voluntary Action Indicated, OAI=Official Action Indicated \u2014 most serious), state, country, city, or date range. Date filters apply to inspection_end_date. OAI inspections typically lead to warning letters. Related: fda_citations (specific CFR violations from inspections by FEI), fda_compliance_actions (warning letters following OAI inspections by FEI).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"city": {
"description": "City name (exact match)",
"maxLength": 500,
"type": "string"
},
"classification_code": {
"description": "Inspection classification code",
"enum": [
"NAI",
"VAI",
"OAI"
],
"type": "string"
},
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"country": {
"description": "Country code (e.g., US, DE)",
"maxLength": 10,
"type": "string"
},
"date_from": {
"description": "Start date for inspection_end_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for inspection_end_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"fei_number": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"state": {
"description": "State code (e.g., CA, NY)",
"maxLength": 10,
"type": "string"
}
},
"type": "object"
},
"name": "fda_inspections",
"title": "Search Inspections"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search specific CFR violation citations from FDA inspections (Compliance Dashboard data, not available in openFDA API). Filter by company name, FEI number, CFR number (e.g., '21 CFR 211.68' for a specific section, or '21 CFR 211' for all cGMP violations), or keyword in citation descriptions. Returns the cited regulation, short and long descriptions of the finding, and inspection dates. Related: fda_inspections (inspection classification and dates by FEI), fda_compliance_actions (warning letters that may reference these citations).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"act_cfr_number": {
"description": "CFR number (exact match)",
"maxLength": 200,
"type": "string"
},
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"fei_number": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"keyword": {
"description": "Keyword to search in citation descriptions",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
}
},
"type": "object"
},
"name": "fda_citations",
"title": "Search Inspection Citations"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA compliance enforcement actions (Compliance Dashboard data, not available in openFDA API): Warning Letters, Seizures, and Injunctions. These are the most serious regulatory outcomes, typically following OAI inspections. Filter by company name, FEI number, action type (Warning Letter/Seizure/Injunction), or date range. Related: fda_inspections (underlying inspection data by FEI), fda_citations (CFR violations cited in these actions).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"action_type": {
"description": "Compliance action type",
"enum": [
"Warning Letter",
"Seizure",
"Injunction"
],
"type": "string"
},
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"date_from": {
"description": "Start date for action_taken_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for action_taken_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"fei_number": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
}
},
"type": "object"
},
"name": "fda_compliance_actions",
"title": "Search Compliance Actions"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search official FDA warning letters with full-text content from the FDA website. Use keyword search for the actual letter body, or filter by company name, issuing office, subject, MARCS-CMS number, product type, or letter issue date. This adds narrative context beyond fda_compliance_actions, which only contains dashboard metadata.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"date_from": {
"description": "Start date for letter_issue_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for letter_issue_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"issuing_office": {
"description": "Issuing office or center name (partial match)",
"maxLength": 500,
"type": "string"
},
"keyword": {
"description": "Full-text query for the warning letter body and subject",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"marcs_cms_number": {
"description": "MARCS-CMS case number shown on the letter page",
"pattern": "^\\d{3,10}$",
"type": "string"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_type": {
"description": "Product type from the letter page (e.g. Drugs, Devices, Food)",
"maxLength": 200,
"type": "string"
},
"subject": {
"description": "Subject line text (partial match)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_warning_letters",
"title": "Search Warning Letters"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search official FDA OPDP untitled letters for pharmaceutical promotion and advertising issues. Filter by company, product, issue date, close-out availability, or keyword in the extracted untitled-letter text when available.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"date_from": {
"description": "Start date for issued_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for issued_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"has_close_out": {
"description": "Whether the record has a linked close-out letter",
"type": "boolean"
},
"keyword": {
"description": "Keyword to search in the extracted untitled-letter text",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_issue": {
"description": "Product or issue text from the OPDP table (partial match)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_opdp_untitled_letters",
"title": "Search OPDP Untitled Letters"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search recent FDA Office of Inspections and Investigations reading-room records by company, FEI, record type, country, establishment type, or publish date. This is official FDA document-index metadata with direct links to the posted records, plus incremental extracted document text when available, useful for finding recent 483-style inspection evidence by account.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"country": {
"description": "Country name",
"maxLength": 200,
"type": "string"
},
"date_from": {
"description": "Start date for publish_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for publish_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"establishment_type": {
"description": "Establishment type, for example Sterile Drug Manufacturer",
"maxLength": 500,
"type": "string"
},
"fei_number": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"keyword": {
"description": "Keyword to search in the FDA-provided excerpt and extracted document text",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"record_type": {
"description": "Record type, for example 483",
"maxLength": 200,
"type": "string"
},
"state": {
"description": "State name",
"maxLength": 200,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_oii_records",
"title": "Search OII Reading Room Records"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search current FDA debarment lists across drug applications, drug imports, and food imports. These are rare but very high-severity compliance signals for people or firms barred from certain FDA-regulated activities.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"date_from": {
"description": "Start date for effective_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for effective_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"list_type": {
"description": "Debarment list type",
"enum": [
"drug_applications",
"drug_imports",
"food_imports"
],
"type": "string"
},
"name": {
"description": "Person or firm name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"subject_type": {
"description": "Whether the record is a person or a firm",
"enum": [
"person",
"firm"
],
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_debarments",
"title": "Search FDA Debarments"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA Import Alerts by firm, alert number, red-list versus green-list status, country, keyword, or date. This is a stronger manufacturing and supplier-risk signal than one-off import refusals because it captures standing alert status and the specific firms currently listed under each alert.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"alert_number": {
"description": "Import alert number, for example 66-40",
"maxLength": 50,
"type": "string"
},
"country": {
"description": "Country name",
"maxLength": 200,
"type": "string"
},
"date_from": {
"description": "Start date for publish-date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for publish-date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"firm_name": {
"description": "Firm name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"keyword": {
"description": "Keyword to search in the alert title, reason, charge, or product notes",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"list_status": {
"description": "Whether the firm is on the red list or green list",
"enum": [
"red",
"green"
],
"type": "string"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"type": "object"
},
"name": "fda_search_import_alerts",
"title": "Search FDA Import Alerts"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA's Biological Product Deviation Report annual summary counts. This is summary-level biotech and blood/HCT/P manufacturing signal from official FDA annual reports, not per-event case detail.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"establishment_type": {
"description": "Establishment type, for example Vaccine or 351 HCT/P",
"maxLength": 200,
"type": "string"
},
"fiscal_year": {
"description": "Metric fiscal year, for example 2024",
"maximum": 2100,
"minimum": 2000,
"type": "integer"
},
"group_name": {
"description": "Group name, for example Licensed Non-Blood Manufacturers",
"maxLength": 200,
"type": "string"
},
"keyword": {
"description": "Keyword to search in group_name or establishment_type",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"row_type": {
"description": "Whether the row is a normal establishment line, subtotal, or total",
"enum": [
"establishment",
"subtotal",
"total"
],
"type": "string"
}
},
"type": "object"
},
"name": "fda_bpdr_summary",
"title": "Search BPDR Annual Summary"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA's current medical device shortage list and discontinuance list. This is an official FDA supply-chain signal for medtech selling, covering shortage categories and permanent discontinuances that may affect customer operations or product availability.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"category": {
"description": "Device category",
"maxLength": 500,
"type": "string"
},
"date_from": {
"description": "Start date for latest_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for latest_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"keyword": {
"description": "Keyword to search descriptions, device names, notes, or reasons",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"list_type": {
"description": "Whether to search the shortage list or discontinuance list",
"enum": [
"shortage",
"discontinuance"
],
"type": "string"
},
"manufacturer_name": {
"description": "Manufacturer name (fuzzy match, discontinuance list only)",
"maxLength": 500,
"type": "string"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_code": {
"description": "FDA product code, for example DSQ or MKJ",
"maxLength": 50,
"type": "string"
}
},
"type": "object"
},
"name": "fda_device_supply_status",
"title": "Search Device Shortages And Discontinuances"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA's official annual inspection-observation summary spreadsheets. This is aggregate Form 483 trend data by product area and citation frequency, not a full company-level 483 corpus. Use it to see which observation areas appear most often in Drugs, Devices, Foods, and other FDA program areas.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"cite_id": {
"description": "FDA citation identifier from the spreadsheet",
"maxLength": 50,
"type": "string"
},
"fiscal_year": {
"description": "Fiscal year of the spreadsheet",
"maximum": 2100,
"minimum": 2000,
"type": "integer"
},
"keyword": {
"description": "Full-text query across short and long citation descriptions",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_area": {
"description": "Product or program area (e.g. Drugs, Devices, Foods)",
"maxLength": 200,
"type": "string"
},
"reference_number": {
"description": "Regulatory citation reference number (e.g. 21 CFR 211.192)",
"maxLength": 200,
"type": "string"
}
},
"type": "object"
},
"name": "fda_inspection_observation_summary",
"title": "Search Inspection Observation Summary"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA import refusals (Compliance Dashboard data, not available in openFDA API). Import refusals indicate products detained at the US border. Filter by company name, FEI number, country code (e.g., CN, IN for major API source countries), or date range. Critical for evaluating international manufacturing sites and supply chain risk. Related: fda_get_facility (facility details by FEI), fda_inspections (inspection history by FEI).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"country_code": {
"description": "ISO country code (e.g. CN, IN)",
"maxLength": 500,
"type": "string"
},
"date_from": {
"description": "Start date for refusal_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for refusal_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"fei_number": {
"description": "FDA Establishment Identifier (FEI number)",
"pattern": "^\\d{1,10}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
}
},
"type": "object"
},
"name": "fda_import_refusals",
"title": "Search Import Refusals"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search iRES enforcement recalls with cross-references to openFDA enforcement data. Filter by company name (fuzzy match), recall number, product type (e.g., Drugs, Devices), or date range. Returns detailed recall info including event classification, product codes, and quantities. Related: fda_search_enforcement (openFDA recall data), fda_recall_facility_trace (trace recall to manufacturing facility).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"date_from": {
"description": "Start date for enforcement_report_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for enforcement_report_date range (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_type": {
"description": "Product type (e.g. Drugs, Devices)",
"maxLength": 500,
"type": "string"
},
"recall_number": {
"description": "Recall number",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_ires_enforcement",
"title": "Search iRES Enforcement"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA drug shortages by generic name, company, status, or availability. Drug shortages signal manufacturing capacity strain, quality issues, or supply chain disruption. Useful for identifying companies with operational challenges. Related: fda_search_drugs (drug application data by company), fda_search_ndc (NDC-level product details).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"generic_name": {
"description": "Generic drug name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"status": {
"description": "Shortage status filter",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_drug_shortages",
"title": "Search Drug Shortages"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA device recalls by recalling firm (fuzzy match), product code, recall status, or date range. Returns device-specific recall details including root cause, event type, and product codes. Complements fda_search_enforcement which covers all product types. Related: fda_search_enforcement (all recalls including drugs), fda_recall_facility_trace (trace to manufacturing facility), fda_device_class (product code details).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"date_from": {
"description": "Start date for event_date_initiated (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"date_to": {
"description": "End date for event_date_initiated (YYYY-MM-DD)",
"pattern": "^\\d{4}-\\d{2}-\\d{2}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_code": {
"description": "Product code",
"maxLength": 5,
"pattern": "^[A-Z]{2,3}$",
"type": "string"
},
"recall_status": {
"description": "Recall status",
"maxLength": 500,
"type": "string"
},
"recalling_firm": {
"description": "Recalling firm name (fuzzy match)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_device_recalls",
"title": "Search Device Recalls"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search consumer adverse events for food and cosmetic products by product area, reaction keyword, or date range (YYYYMMDD format). Returns reports including outcomes, reactions, and product details.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"date_from": {
"description": "Start date for date_created (YYYYMMDD)",
"pattern": "^\\d{8}$",
"type": "string"
},
"date_to": {
"description": "End date for date_created (YYYYMMDD)",
"pattern": "^\\d{8}$",
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_area": {
"description": "Filter by product area: food or cosmetic",
"enum": [
"food",
"cosmetic"
],
"type": "string"
},
"reaction": {
"description": "Reaction keyword (searches reactions array)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_consumer_events",
"title": "Search Consumer Adverse Events"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search veterinary adverse events (animal drug safety reports) by species, drug name, reaction, serious flag, or date range (YYYYMMDD format). Returns event reports including animal details, drug information, and adverse reactions. Related: fda_search_aphis (veterinary biologics facilities and establishments).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"date_from": {
"description": "Start receive_date (YYYYMMDD)",
"pattern": "^\\d{8}$",
"type": "string"
},
"date_to": {
"description": "End receive_date (YYYYMMDD)",
"pattern": "^\\d{8}$",
"type": "string"
},
"drug_name": {
"description": "Drug name (searches drug JSONB)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"serious": {
"description": "Filter by serious adverse event",
"enum": [
"true",
"false"
],
"type": "string"
},
"species": {
"description": "Animal species (searches animal JSONB)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_vet_events",
"title": "Search Veterinary Adverse Events"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search tobacco problem reports by product type or health problem keyword. Date range in YYYYMMDD format. Returns reports including tobacco product details and reported health problems.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"date_from": {
"description": "Start date_submitted (YYYYMMDD)",
"pattern": "^\\d{8}$",
"type": "string"
},
"date_to": {
"description": "End date_submitted (YYYYMMDD)",
"pattern": "^\\d{8}$",
"type": "string"
},
"health_problem": {
"description": "Reported health problem keyword",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_type": {
"description": "Tobacco product type (searches tobacco_products array)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_tobacco_problems",
"title": "Search Tobacco Problem Reports"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Look up FDA substance data by UNII code (exact match) or substance name (fuzzy match). Returns substance name, UNII, substance class, molecular formula, and related details. Use to identify active pharmaceutical ingredients.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"substance_name": {
"description": "Substance name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"unii": {
"description": "UNII code (exact match)",
"maxLength": 20,
"type": "string"
}
},
"type": "object"
},
"name": "fda_substance_lookup",
"title": "Substance Lookup"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search the National Standard Drug Element (NSDE) database by brand/proprietary name, application number, or package NDC. Returns proprietary name, active ingredients, dosage form, route, and marketing information. Related: fda_search_ndc (NDC directory), fda_search_drugs (Drugs@FDA application data).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"application_number": {
"description": "Application number (exact match)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"package_ndc": {
"description": "Package NDC (exact match)",
"maxLength": 500,
"type": "string"
},
"proprietary_name": {
"description": "Brand/proprietary name (fuzzy match)",
"maxLength": 500,
"type": "string"
}
},
"type": "object"
},
"name": "fda_search_nsde",
"title": "Search NSDE"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA Complete Response Letters (CRLs) \u2014 formal refusal-to-approve decisions on drug and biologics applications. Filter by company name (fuzzy match), application number (e.g., 'NDA 204017'), or letter type. CRLs are significant regulatory events indicating application deficiencies. Related: fda_search_drugs (drug application data including approval status).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"application_number": {
"description": "Application number (searches array, e.g. 'NDA 204017')",
"maxLength": 500,
"type": "string"
},
"company_name": {
"description": "Company name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"letter_type": {
"description": "Letter type filter (e.g. 'COMPLETE RESPONSE')",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"type": "object"
},
"name": "fda_clinical_result_letters",
"title": "Search Complete Response Letters"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search FDA Structured Product Labeling (SPL) data \u2014 full drug package inserts. Filter by drug name, manufacturer, application number, or specific label section (e.g., indications_and_usage, warnings, adverse_reactions, boxed_warning). Returns complete label text for matching sections. Related: fda_search_drugs (application-level data), fda_search_ndc (NDC product details).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"application_number": {
"description": "NDA or ANDA application number",
"maxLength": 100,
"type": "string"
},
"drug_name": {
"description": "Brand or generic drug name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 20,
"description": "Result limit",
"maximum": 100,
"minimum": 1,
"type": "integer"
},
"manufacturer": {
"description": "Manufacturer name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"offset": {
"default": 0,
"description": "Result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"section": {
"description": "Specific label section to return (e.g. indications_and_usage, warnings, adverse_reactions)",
"maxLength": 100,
"type": "string"
}
},
"type": "object"
},
"name": "fda_drug_labels",
"title": "Search Drug Labels"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search the FDA Unique Device Identification (UDI) database by brand name, company/manufacturer name, product code, or DI number. Returns device identification data including brand name, company, device description, product codes, GMDN terms, sterilization info, and premarket submissions. Related: fda_device_class (classification details by product code), fda_search_510k (clearances by product code).",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"brand_name": {
"description": "Device brand name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"company_name": {
"description": "Company/manufacturer name (fuzzy match)",
"maxLength": 500,
"type": "string"
},
"di_number": {
"description": "Device Identifier (DI) number",
"maxLength": 100,
"type": "string"
},
"limit": {
"default": 20,
"description": "Result limit",
"maximum": 100,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
},
"product_code": {
"description": "FDA product code (3-letter code, e.g. OVE)",
"maxLength": 5,
"pattern": "^[A-Z]{2,3}$",
"type": "string"
}
},
"type": "object"
},
"name": "fda_device_udi",
"title": "Search Device UDI"
},
{
"annotations": {
"idempotentHint": true,
"openWorldHint": false,
"readOnlyHint": true
},
"description": "Search the FDA's Global Unique Device Identification Database (GUDID) by device identifier (DI/barcode), device name, company name, or brand name. Returns device details including UDI, descriptions, and company information. Costs 1 credit.",
"execution": {
"taskSupport": "forbidden"
},
"inputSchema": {
"$schema": "http://json-schema.org/draft-07/schema#",
"properties": {
"brand_name": {
"description": "Brand name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"company_name": {
"description": "Company/manufacturer name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"device_id": {
"description": "Device Identifier (DI) \u2014 exact barcode/GTIN lookup",
"maxLength": 100,
"type": "string"
},
"device_name": {
"description": "Device/brand name (fuzzy search)",
"maxLength": 500,
"type": "string"
},
"limit": {
"default": 100,
"description": "Max results to return (1-500)",
"maximum": 500,
"minimum": 1,
"type": "integer"
},
"offset": {
"default": 0,
"description": "Result offset for pagination",
"maximum": 9007199254740991,
"minimum": 0,
"type": "integer"
}
},
"type": "object"
},
"name": "fda_device_udi_lookup",
"title": "Device UDI Lookup"
}
]
}
},
"requested_protocol_version": "2025-03-26",
"resumed": true,
"session_id_present": true,
"transport": "streamable-http",
"url": "https://www.regdatalab.com/mcp"
},
"latency_ms": 32.09,
"status": "ok"
},
"step_up_auth_probe": {
"details": {
"auth_required_checks": [],
"broad_scopes": [],
"challenge_headers": [],
"minimal_scope_documented": false,
"oauth_present": false,
"scope_specificity_ratio": 0.0,
"step_up_signals": [],
"supported_scopes": []
},
"latency_ms": null,
"status": "missing"
},
"tool_snapshot_probe": {
"details": {
"reason": "no_tools"
},
"latency_ms": null,
"status": "missing"
},
"tools_list": {
"details": {
"error": "Client error '400 Bad Request' for url 'https://www.regdatalab.com/mcp'\nFor more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/400",
"headers": {
"content-type": "application/json; charset=utf-8",
"strict-transport-security": "max-age=31536000; includeSubDomains"
},
"http_status": 400,
"payload": {},
"url": "https://www.regdatalab.com/mcp"
},
"latency_ms": 29.61,
"status": "error"
},
"transport_compliance_probe": {
"details": {
"bad_protocol_error": null,
"bad_protocol_headers": {
"content-type": "application/json",
"strict-transport-security": "max-age=31536000; includeSubDomains"
},
"bad_protocol_payload": {
"error": {
"code": -32000,
"message": "Bad Request: Unsupported protocol version: 1999-99-99 (supported versions: 2025-11-25, 2025-06-18, 2025-03-26, 2024-11-05, 2024-10-07)"
},
"id": null,
"jsonrpc": "2.0"
},
"bad_protocol_status_code": 400,
"delete_error": null,
"delete_status_code": 200,
"expired_session_error": null,
"expired_session_status_code": 404,
"issues": [
"missing_protocol_header"
],
"last_event_id_visible": false,
"protocol_header_present": false,
"requested_protocol_version": "2025-03-26",
"session_id_present": true,
"transport": "streamable-http"
},
"latency_ms": 29.08,
"status": "warning"
},
"utility_coverage_probe": {
"details": {
"completions": {
"advertised": false,
"live_probe": "not_executed",
"sample_target": null
},
"initialize_capability_keys": [
"resources",
"tools"
],
"pagination": {
"metadata_signal": false,
"next_cursor_methods": [],
"supported": false
},
"tasks": {
"advertised": false,
"http_status": 400,
"probe_status": "missing"
}
},
"latency_ms": 9.84,
"status": "missing"
}
},
"failures": {
"oauth_authorization_server": {
"reason": "no_authorization_server"
},
"oauth_protected_resource": {
"error": "Client error '404 Not Found' for url 'https://www.regdatalab.com/.well-known/oauth-protected-resource'\nFor more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/404",
"url": "https://www.regdatalab.com/.well-known/oauth-protected-resource"
},
"openid_configuration": {
"reason": "no_authorization_server"
},
"tools_list": {
"error": "Client error '400 Bad Request' for url 'https://www.regdatalab.com/mcp'\nFor more information check: https://developer.mozilla.org/en-US/docs/Web/HTTP/Status/400",
"headers": {
"content-type": "application/json; charset=utf-8",
"strict-transport-security": "max-age=31536000; includeSubDomains"
},
"http_status": 400,
"payload": {},
"url": "https://www.regdatalab.com/mcp"
}
},
"remote_url": "https://www.regdatalab.com/mcp",
"server_card_payload": {
"auth": {
"free_credits_per_month": 300,
"header": "Authorization: Bearer YOUR_API_KEY",
"required_for_tool_calls": true,
"signup_url": "https://www.regdatalab.com/signup"
},
"description": "Manufacturing-first FDA intelligence for Claude Desktop, Cowork, and other MCP clients.",
"name": "FDA Data MCP",
"server_url": "https://www.regdatalab.com/mcp",
"signup_url": "https://www.regdatalab.com/signup",
"wrapper": {
"command": "FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp",
"package": "fda-data-mcp"
}
},
"server_identifier": "io.github.medley/fda-data"
}
Known versions
1.0.0
Validation history
7 day score delta
-0.1
30 day score delta
n/a
Recent healthy ratio
0%
Freshness
65.6h
| Timestamp | Status | Score | Latency | Tools |
|---|---|---|---|---|
| May 01, 2026 12:17:24 PM UTC | Failing | 58.0 | 1640.8 ms | 0 |
| Apr 30, 2026 04:16:43 PM UTC | Failing | 52.9 | 22747.2 ms | 0 |
| Apr 29, 2026 09:07:40 PM UTC | Failing | 58.2 | 682.9 ms | 0 |
| Apr 29, 2026 12:58:21 AM UTC | Failing | 58.2 | 524.3 ms | 0 |
| Apr 28, 2026 04:50:41 AM UTC | Failing | 58.2 | 608.5 ms | 0 |
| Apr 27, 2026 09:39:58 AM UTC | Failing | 58.2 | 544.5 ms | 0 |
| Apr 26, 2026 02:32:45 PM UTC | Failing | 58.2 | 579.9 ms | 0 |
| Apr 25, 2026 07:28:25 PM UTC | Failing | 58.2 | 988.2 ms | 0 |
Validation timeline
| Validated | Summary | Score | Protocol | Auth mode | Tools | High-risk tools | Changes |
|---|---|---|---|---|---|---|---|
| May 01, 2026 12:17:24 PM UTC | Failing | 58.0 | 2025-03-26 | public | 0 | 0 | auth_mode_changed |
| Apr 30, 2026 04:16:43 PM UTC | Failing | 52.9 | unknown | unknown | 0 | 0 | auth_mode_changed |
| Apr 29, 2026 09:07:40 PM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 29, 2026 12:58:21 AM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 28, 2026 04:50:41 AM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 27, 2026 09:39:58 AM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 26, 2026 02:32:45 PM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 25, 2026 07:28:25 PM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 25, 2026 12:23:06 AM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 24, 2026 05:16:57 AM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 23, 2026 10:22:24 AM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
| Apr 22, 2026 04:10:16 PM UTC | Failing | 58.2 | 2025-03-26 | public | 0 | 0 | none |
Recent validation runs
| Started | Status | Summary | Latency | Checks |
|---|---|---|---|---|
| May 01, 2026 12:17:22 PM UTC | Completed | Failing | 1640.8 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 30, 2026 04:16:20 PM UTC | Completed | Failing | 22747.2 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 29, 2026 09:07:39 PM UTC | Completed | Failing | 682.9 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 29, 2026 12:58:20 AM UTC | Completed | Failing | 524.3 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 28, 2026 04:50:40 AM UTC | Completed | Failing | 608.5 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 27, 2026 09:39:57 AM UTC | Completed | Failing | 544.5 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 26, 2026 02:32:45 PM UTC | Completed | Failing | 579.9 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 25, 2026 07:28:24 PM UTC | Completed | Failing | 988.2 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 25, 2026 12:23:05 AM UTC | Completed | Failing | 617.4 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |
| Apr 24, 2026 05:16:57 AM UTC | Completed | Failing | 566.6 ms | action_safety_probe, advanced_capabilities_probe, connector_publishability_probe, connector_replay_probe, determinism_probe, initialize, interactive_flow_probe, oauth_authorization_server, oauth_protected_resource, official_registry_probe, openid_configuration, probe_noise_resilience, prompt_get, prompts_list, protocol_version_probe, provenance_divergence_probe, request_association_probe, resource_read, resources_list, server_card, session_resume_probe, step_up_auth_probe, tool_snapshot_probe, tools_list, transport_compliance_probe, utility_coverage_probe |