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Fda Inspections

NPM · @PIPEWORX/MCP-FDA-INSPECTIONS · 2 COMPONENTS

FDA inspection outcomes, Form 483 observations, compliance actions and import refusals for drug…

+3 this week 81 Trust /100

Last scanned (7 hours ago)

Scores higher than 69% of npm servers

Category Health and Science

Trust breakdown (7 categories)

How this component scores in each security and reliability category. Every signal is checked automatically from public evidence about the published package, including repeated runs of it in an isolated sandbox, and we only credit what we can confirm. How we score → Why this is hard to score →

Supply Chain Security100
  • No malware found by supply-chain analysis.Pass
  • No known CVEs affecting this package version or its production dependencies.Pass
  • No install/post-install scripts declared.Pass
  • No production dependencies, so there is no dependency health to assess. View diagnostics → Pass
Provenance & Transparency97
  • Source repository is publicly reachable at the declared URL. View diagnostics → Pass
  • Cryptographically verified build provenance (signed, bound to pipeworx-io/mcp-fda-inspections). View diagnostics → Pass
  • Clear OSI-approved license (MIT).Pass
  • Actively maintained (last published 3 days ago).Pass
  • Disclosure check failed: no security disclosure policy was found in the source repository. See how to fix → Fail
Schema Quality & AI Usability59
  • AI-judged instruction clarity (good).Pass
  • Context-footprint check failed: tool/resource definitions use about 1361 tokens (~272/item across 5 items; 5 tools + 0 resources), over budget; trim descriptions and params. See how to fix → Fail
  • Usage-examples check failed: none of the tools include examples. See how to fix → Fail
Stability & Change Management23
  • Stability observed for 7 of 30 days with no destabilising changes; credit accrues until the full window elapses.Partial
Tool Coverage100
  • 100% of tools have a non-trivial description (not blank, and not just the tool's name).Pass
  • 100% of tool parameters carry a description.Pass
Tool Safety100
  • No prompt-injection markers were found in the server instructions, tool names or descriptions we captured.Pass
  • We read all 5 captured tool definition(s), and no name or description among them implies an irreversible operation.Pass
  • An AI judge read all 6 captured unit(s) of tool text and found none that tries to manipulate the model reading it.Pass
Capabilities100
  • Implements a supported MCP spec version (2025-11-25); the latest is 2026-07-28.Pass
Changelog

Every change we have recorded for this component, newest first. Security-relevant changes are always shown. ▲ marks a change for the better, ▼ a change for the worse; unmarked changes are neutral.

  • 4 Nov 26 +1

    No change was recorded against any check on this day. Stability & Change Management went from 17 to 20. That category is still filling its 30-day observation window: 5 days of observed history at the previous scan, 6 at this one. The score rises as the window fills, whether or not the server changes.

  • 2 Nov 26 +1

    No change was recorded against any check on this day. Stability & Change Management went from 10 to 13. That category is still filling its 30-day observation window: 3 days of observed history at the previous scan, 4 at this one. The score rises as the window fills, whether or not the server changes.

  • 1 Nov 26 +1
    • Tool safety: pass → unverified ▼ security
    • Stability: Stability not yet verified: we do not have a sandbox capture of the MCP schema this version of the package serves yet. security
    • Tool coverage: 100 → unverified ▼ functional
    • Capabilities: pass → unverified ▼ functional
    • Security disclosure: fail → unverified ▼ functional
    • Stability: unverified → 0.10 ▲ functional
    • First check of Schema quality: unverified functional
    • Package version: 0.2.0 → 0.2.1 functional
  • 30 Oct 26 0
    • Security disclosure: unverified → fail ▼ functional
  • 29 Oct 26 78

    First indexed and scored.

Diagnostics

Diagnostic detail from the automated scan of this channel: what the scanner observed at each step, so you can see exactly where a check passed or failed. It is informational only and never changes the trust score.

Captured 5 Nov 2026 · Analysed npm/@pipeworx/mcp-fda-inspections@0.2.1

Provenance Verified

A signed build attestation was found and verified, binding this exact artifact to the source repository it claims to come from.

Result Verified
Ecosystem npm
Reason Verified
Discovered via Registry attestation endpoint
Source repo pipeworx-io/mcp-fda-inspections
Certificate issuer https://token.actions.githubusercontent.com
Certificate SAN https://github.com/pipeworx-io/mcp-fda-inspections/.github/workflows/publish.yml@refs/heads/main
Rekor log index 3635938969
Predicate type SLSA build provenance https://slsa.dev/provenance/v1
Subject digest sha512:39a744c5b8a564dbd2f503b028d0a183d0a3e9c23e7d7c8799789f263e6874ac1c4df9f54c45844b6ece77981ea6b8ce17d0191daf5c4d7f8ceb38657

Background: How many MCP packages publish verified provenance →

Dependencies 0 packages
Packages resolved 0
Tree resolution Complete

Background: SBOMs and build attestations, explained →

MCP tools · 5 exposed · ~1,305 tokens

The tools this component advertises to a client, with an estimated token cost for each. Expand a tool to see its parameters and schema. The per-tool counts are indicative and are not scored directly; the schema's total context footprint is one signal in Schema Quality & AI Usability. A tool's description is untrusted text the model reads on every call, which is what makes this list a security surface and not just an inventory: how tool poisoning works →

Tool Tokens
fda_483_citations ~258

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 by firm, country, state or date range. Source: FDA Data Dashboard (OII).

NameTypeReqDescription
_apiKeystring–FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
cfrstring–CFR citation substring, e.g. "211.192".
countrystring–Country name, e.g. "India".
firmstring–Firm legal-name substring.
fiscal_yearstring–FDA fiscal year, e.g. "2026".
limitnumber–Rows to return (default 50, max 5000).
sincestring–Earliest inspection end date, YYYY-MM-DD.
statestring–US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
untilstring–Latest inspection end date, YYYY-MM-DD.

No output schema declared.

No examples provided.

fda_compliance_actions ~255

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 or date range. Source: FDA Data Dashboard (OII).

NameTypeReqDescription
_apiKeystring–FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
action_typestring–Action type substring, e.g. "Warning Letter".
countrystring–Country name.
firmstring–Firm legal-name substring.
fiscal_yearstring–FDA fiscal year.
limitnumber–Rows to return (default 50, max 5000).
product_typestring–e.g. "Drugs", "Devices".
sincestring–Earliest action date, YYYY-MM-DD.
statestring–US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
untilstring–Latest action date, YYYY-MM-DD.

No output schema declared.

No examples provided.

fda_firm_risk_profile ~199

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 refusals at the border. Resolves the firm name to its FDA establishment identifiers (FEI) so you can see whether several sites are involved. Use this for supplier due-diligence or to check a pharma name before an investment or sourcing decision.

NameTypeReqDescription
_apiKeystring–FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
firmstringyesFirm name substring, e.g. "Intas".
limitnumber–Rows to scan per source (default 200, max 5000).
sincestring–Only count events on/after this date, YYYY-MM-DD.

No output schema declared.

No examples provided.

fda_import_refusals ~245

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, country, product or date range. Source: FDA Data Dashboard (OII).

NameTypeReqDescription
_apiKeystring–FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
countrystring–Country of origin, e.g. "India".
firmstring–Firm name substring (this resource keys on FirmName).
limitnumber–Rows to return (default 50, max 5000).
productstring–Product-code description substring, e.g. "Antibiotic".
sincestring–Earliest refusal date, YYYY-MM-DD.
statestring–US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
untilstring–Latest refusal date, YYYY-MM-DD.

No output schema declared.

No examples provided.

fda_inspections ~348

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 establishments worldwide (drug, device, food, biologics), not just US sites. Search by firm name (substring), state, country, product type or date range. Source: FDA Data Dashboard (OII). This is inspection OUTCOME data — openFDA does not carry it.

NameTypeReqDescription
_apiKeystring–FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
classificationstring–Final classification: NAI, VAI or OAI. OAI is the one that signals enforcement risk.
countrystring–Country name as FDA spells it, e.g. "India", "China".
firmstring–Firm legal-name substring, e.g. "Intas" or "Sun Pharma".
fiscal_yearstring–FDA fiscal year, e.g. "2026".
limitnumber–Rows to return (default 50, max 5000).
product_typestring–e.g. "Drugs", "Devices", "Foods", "Biologics".
sincestring–Earliest inspection end date, YYYY-MM-DD.
statestring–US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
untilstring–Latest inspection end date, YYYY-MM-DD.

No output schema declared.

No examples provided.

Install

How do I install the Fda Inspections MCP server?

Fda Inspections runs locally as an npm package, launched with npx -y @pipeworx/mcp-fda-inspections. Ready-made configuration for Claude, Cursor, VS Code, Codex and 5 more is on this page, copied from each client's own documentation.

npm · @pipeworx/mcp-fda-inspections

# add to Claude Code
claude mcp add pipeworx-io-fda-inspections -- npx -y @pipeworx/mcp-fda-inspections
Common questions

What is the Fda Inspections MCP server?

Fda Inspections is an MCP server listed in the public MCP registry as io.github.pipeworx-io/fda-inspections. FDA inspection outcomes, Form 483 observations, compliance actions and import refusals for drug… This page covers its npm package (@pipeworx/mcp-fda-inspections).

Is the Fda Inspections MCP server safe to use?

Fda Inspections scores 81 out of 100 on VerifyMCP. We found no known CVEs affecting it as of 5 November 2026. It declares no install or post-install scripts. Its build provenance is signed and verified. That is a record of what we were able to check automatically, not an endorsement. The category breakdown on this page shows every signal behind the number, including the ones we could not confirm.

What tools does the Fda Inspections MCP server expose?

Fda Inspections exposes 5 tools: fda_inspections, fda_483_citations, fda_compliance_actions, fda_import_refusals, fda_firm_risk_profile. Their descriptions and schemas cost roughly 1,305 tokens of context every time the server is loaded.

Is the Fda Inspections MCP server still maintained?

Fda Inspections is still listed as active in the MCP registry. We last reached this channel on 5 November 2026. Those dates come from our own scans of the registry and the channel itself, not from anything the publisher announced.

What licence is the Fda Inspections MCP server under?

Fda Inspections declares the MIT licence, which is OSI-approved. That covers the source only, and says nothing about the cost of any service it calls.