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 1576+ live data sources.

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

Tool	Answers
fda_inspections	Was this site inspected, and what was the outcome (NAI / VAI / OAI)?
fda_483_citations	Why was it cited — which CFR section, and what did the investigator write?
fda_compliance_actions	What enforcement followed — warning letter, injunction, seizure, debarment?
fda_import_refusals	What shipments were refused at the border, and on what charge?
fda_firm_risk_profile	All four at once for one manufacturer, with the FEI sites resolved.

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 counts, which are computed over all matched rows.

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.

Quick Start

Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):

{
  "mcpServers": {
    "fda-inspections": {
      "url": "https://gateway.pipeworx.io/fda-inspections/mcp"
    }
  }
}

What this endpoint actually serves

tools/list at https://gateway.pipeworx.io/fda-inspections/mcp returns the tools in the table above plus the shared Pipeworx meta-tools — ask_pipeworx, discover_tools, search_within, remember/recall and the rest of the gateway-wide set. So the tool count you see is larger than this table: a single-pack endpoint currently lists roughly 30 shared tools alongside the pack's own. The connection's initialize response states its exact scope, and is the authoritative answer for a given day.

This is deliberate, not multiplexing by accident. The meta-tools are what let a scoped connection answer a question this pack does not cover — via ask_pipeworx, which routes across the whole catalog — without you adding a second MCP server. There is currently no way to mount a pack endpoint without them; if the extra schemas cost you more context than the routing is worth, connect to the full gateway once rather than to several pack endpoints.

Or connect to the full Pipeworx gateway to get every pack's tools listed directly, instead of just this one's:

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://gateway.pipeworx.io/mcp"
    }
  }
}

Both URLs reach the same gateway and the same 1576+ data sources. The only difference is which pack's tools are listed directly; ask_pipeworx reaches all of them from either one.

Standalone (no gateway account)

This package also runs as a local stdio MCP server — no Pipeworx account, no gateway round-trip:

{
  "mcpServers": {
    "fda-inspections": {
      "command": "npx",
      "args": ["-y", "@pipeworx/mcp-fda-inspections"]
    }
  }
}

Or run it directly to confirm it starts:

npx -y @pipeworx/mcp-fda-inspections

It speaks MCP over stdin/stdout and answers initialize/tools/list/tools/call for only this pack's tools — none of the shared meta-tools the gateway connection above adds. Same source, same tools, no ask_pipeworx routing.

Using with ask_pipeworx

Instead of calling tools directly, you can ask questions in plain English — this works on the pack endpoint above as well as on the full gateway:

ask_pipeworx({ question: "your question about Fda Inspections data" })

The gateway picks the right tool and fills the arguments automatically.

More

• Docs and guides
• pipeworx.io

License

MIT