fda-inspections

FDA inspection outcomes, Form 483 citations, compliance actions and import refusals, from the FDA Data Dashboard (Office of Inspections and Investigations).

Part of Pipeworx — an MCP gateway connecting AI agents to 1864+ live data sources. This is an independent, unofficial integration — not affiliated with, endorsed by, or published by the upstream provider.

This is not openFDA. openFDA carries drug/device adverse events, labels, recalls and warning letters. It does not carry inspection classifications, 483 observations, or border refusals — those live only in OII's own Data Dashboard, on a different host with a different credential.

Tools

Auth

The credential is a pair, not a single key:

Authorization-User: <the e-mail it was issued to>
Authorization-Key:  <the FDA-generated key>

Pass it as _apiKey in the combined form "email:key" (split on the first colon). Platform secret: PLATFORM_FDA_DASHBOARD_KEY, same combined form, set on both the gateway and registry-api workers.

Credentials are free: create an account in the OII Unified Logon application at https://www.accessdata.fda.gov/scripts/oul and request Data Dashboard API access. FDA mails the key to the address you register, and that address becomes the Authorization-User value. The platform credential is set, so callers need no key of their own.

Note that datadashboard.fda.gov serves a 403 to a default curl User-Agent — send a browser UA when reading the docs by hand. The API host (api-datadashboard.fda.gov) has no such restriction.

Request contract

Verified against the live endpoint rather than assumed — a malformed body returns 400 and names the offending field, a well-formed but unauthenticated one returns 401, which makes the shape testable without a credential.

• POST https://api-datadashboard.fda.gov/v1/<resource>
• Body: { start, rows, sort, sortorder, columns[], filters{} }
• sort and sortorder are required, not optional.
• start is 1-based.
• rows maxes at 5000.
• columns is required — omitting it 400s and names the missing field.
• Filter values must be arrays — {"State": ["California"]}. A bare string 400s.
• Date ranges use suffixed keys: InspectionEndDateFrom / InspectionEndDateTo. There is no top-level date-range parameter, and the bare date fieldname is rejected as a filter key.
• Most string filters match LIKE %term% case-insensitively, so firm names are substring searches. State is the exception — see below.

Gotcha: State is exact, and a wrong one looks like "never inspected"

LegalName, FirmName and CountryName are case-insensitive substring matches. State is exact and case-sensitive against the spelled-out name. "CA", "Ca" and "CALIFORNIA" each return a clean 200 with resultcount: 0 — which reads as this site was never inspected rather than you passed the wrong argument. Only "California" returns data.

The pack normalizes postal codes and casing (normalizeState), so callers may pass either form. Foreign establishments carry State: null; filter those by country instead.

Gotcha: firm search is a substring, so it over-matches

firm: "Intas" also matches Cintas Corporation. fda_firm_risk_profile returns every FEI it matched in matched_establishments precisely so this is visible — read that list before quoting the aggregate co

... View full README on GitHub