The full upstream README, mirrored here for reference. Install config, tool schemas, adoption signals, and an original overview live on the Fda Inspections listing page.
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 1679+ 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.
| 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. |
The credential is a pair, not a single 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.
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>{ 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.{"State": ["California"]}. A bare string 400s.InspectionEndDateFrom /
InspectionEndDateTo. There is no top-level date-range parameter, and the
bare date fieldname is rejected as a filter key.LIKE %term% case-insensitively, so firm names are
substring searches. State is the exception — see below.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.
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.
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.
Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):
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:
Both URLs reach the same gateway and the same 1679+ data sources. The
only difference is which pack's tools are listed directly; ask_pipeworx
reaches all of them from either one.
No account needed for the first calls. Inspect any tool: GET https://gateway.pipeworx.io/v1/tools/fda_inspections. Find one: POST https://gateway.pipeworx.io/v1/tools/search_packs with {"query":"..."}.
This package also runs as a local stdio MCP server — no Pipeworx account, no gateway round-trip:
Or run it directly to confirm it starts:
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.
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:
The gateway picks the right tool and fills the arguments automatically.
MIT