@pipeworx/fda-inspections

Connect: https://gateway.pipeworx.io/fda-inspections/mcp · Install: one-click buttons

Tools: 5

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

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 but issued by hand: request one through the OII Unified Logon application linked from https://datadashboard.fda.gov/oii/api/. FDA mails the key back to the address you register, and that address becomes the Authorization-User value.

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.
• Filter values must be arrays — {"State": ["CA"]}. 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.
• String filters match LIKE %term%, so firm names are substring searches.

Gotcha: the name column is not uniform

import_refusals calls it FirmName. The other three resources use LegalName. Sending the wrong one is rejected as an invalid fieldname, so the pack encodes the name column per resource instead of assuming one.

Tools

• fda_inspections — FDA inspection results with their final classification — NAI (no action indicated), VAI (voluntary action indicated) or OAI (official action indicated, the serious one). Covers FDA-regulated establish
• fda_483_citations — Individual Form 483 observations cited during FDA inspections — the specific CFR reference and what the investigator actually wrote. Use this to see WHY a site was cited, not just that it was. Search
• fda_compliance_actions — FDA compliance and enforcement actions taken against a firm — warning letters, injunctions, seizures, debarments — with the action type and the date taken. Search by firm, country, state, product type
• fda_import_refusals — Shipments refused entry to the US by FDA at the border, with the refusal charges (the reason), product code and date. A leading indicator of supply risk for a foreign manufacturer. Search by firm, cou
• fda_firm_risk_profile — One-call FDA regulatory risk profile for a manufacturer: inspection history with the NAI/VAI/OAI split, the CFR sections it is most often cited under, compliance actions taken against it, and import r