# Fda Inspections (npm · @pipeworx/mcp-fda-inspections)

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

- Trust score: 81/100 (high trust)
- Change this week: +3
- Registry status: active
- Liveness: live
- Owner verified: no
- Last scored: 2026-11-05

## Components

- remote · `gateway.pipeworx.io`: 77/100, [markdown](https://verifymcp.io/servers/pipeworx-io-fda-inspections/fda-inspections-mcp.md), [page](https://verifymcp.io/servers/pipeworx-io-fda-inspections/fda-inspections-mcp)
- npm · `@pipeworx/mcp-fda-inspections`: 81/100 (this document), [markdown](https://verifymcp.io/servers/pipeworx-io-fda-inspections/pipeworx-mcp-fda-inspections.md), [page](https://verifymcp.io/servers/pipeworx-io-fda-inspections/pipeworx-mcp-fda-inspections)

## Channel facts

- Registry: `npm`
- Package: `@pipeworx/mcp-fda-inspections`
- Version: `0.2.1`
- Transport: `stdio`

## Trust breakdown

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. Scores are 0–100 per category. Scoring method: https://verifymcp.io/docs/scoring (what has changed: https://verifymcp.io/docs/scoring/changelog)

Scored 2026-11-05.

- **Supply Chain Security**: 100/100
  - No malware found by supply-chain analysis.
  - No known CVEs affecting this package version or its production dependencies.
  - No install/post-install scripts declared.
  - No production dependencies, so there is no dependency health to assess.
- **Provenance & Transparency**: 97/100
  - Source repository is publicly reachable at the declared URL.
  - Cryptographically verified build provenance (signed, bound to pipeworx-io/mcp-fda-inspections).
  - Clear OSI-approved license (MIT).
  - Actively maintained (last published 3 days ago).
  - Disclosure check failed: no security disclosure policy was found in the source repository.
- **Schema Quality & AI Usability**: 59/100
  - AI-judged instruction clarity (good).
  - 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.
  - Usage-examples check failed: none of the tools include examples.
- **Stability & Change Management**: 23/100
  - Stability observed for 7 of 30 days with no destabilising changes; credit accrues until the full window elapses.
- **Tool Coverage**: 100/100
  - 100% of tools have a non-trivial description (not blank, and not just the tool's name).
  - 100% of tool parameters carry a description.
- **Tool Safety**: 100/100
  - No prompt-injection markers were found in the server instructions, tool names or descriptions we captured.
  - We read all 5 captured tool definition(s), and no name or description among them implies an irreversible operation.
  - An AI judge read all 6 captured unit(s) of tool text and found none that tries to manipulate the model reading it.
- **Capabilities**: 100/100
  - Implements a supported MCP spec version (2025-11-25); the latest is 2026-07-28.

## 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.

### Claude

```bash
claude mcp add pipeworx-io-fda-inspections -- npx -y @pipeworx/mcp-fda-inspections
```

### Cursor

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

### VS Code

```json
{
  "servers": {
    "pipeworx-io-fda-inspections": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-inspections"
      ]
    }
  }
}
```

### Codex

```bash
codex mcp add pipeworx-io-fda-inspections -- npx -y @pipeworx/mcp-fda-inspections
```

### opencode

```json
{
  "$schema": "https://opencode.ai/config.json",
  "mcp": {
    "pipeworx-io-fda-inspections": {
      "type": "local",
      "command": [
        "npx",
        "-y",
        "@pipeworx/mcp-fda-inspections"
      ],
      "enabled": true
    }
  }
}
```

### OpenClaw

```bash
openclaw mcp add pipeworx-io-fda-inspections --command npx --arg -y --arg @pipeworx/mcp-fda-inspections
```

### Hermes

```yaml
mcp_servers:
  pipeworx-io-fda-inspections:
    command: "npx"
    args: ["-y", "@pipeworx/mcp-fda-inspections"]
```

### Netclaw

```json
{
  "McpServers": {
    "pipeworx-io-fda-inspections": {
      "Transport": "stdio",
      "Command": "npx",
      "Arguments": [
        "-y",
        "@pipeworx/mcp-fda-inspections"
      ]
    }
  }
}
```

### Vellum

```bash
assistant mcp add pipeworx-io-fda-inspections -t stdio -c npx -a -y @pipeworx/mcp-fda-inspections
```

### Other

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

## Changelog

Every change recorded for this component, newest first. Days that predate change tracking, or that we cannot explain, say so: "we were watching and nothing happened" and "we were not watching" are different claims.

### 2026-11-04 (score 81, +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.

### 2026-11-02 (score 80, +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.

### 2026-11-01 (score 79, +1)

- [security regression] 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.
- [functional regression] Tool coverage: 100 → unverified
- [functional regression] Capabilities: pass → unverified
- [functional regression] Security disclosure: fail → unverified
- [functional improvement] Stability: unverified → 0.10
- [functional] First check of Schema quality: unverified
- [functional] Package version: 0.2.0 → 0.2.1

### 2026-10-30 (score 78, 0)

- [functional regression] Security disclosure: unverified → fail

### 2026-10-29 (score 78)

First indexed and scored.

## MCP tools (5)

### `fda_inspections` (~348 tokens)

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.

Input parameters:

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

### `fda_483_citations` (~258 tokens)

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).

Input parameters:

- `_apiKey` (string): FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
- `cfr` (string): CFR citation substring, e.g. "211.192".
- `country` (string): Country name, e.g. "India".
- `firm` (string): Firm legal-name substring.
- `fiscal_year` (string): FDA fiscal year, e.g. "2026".
- `limit` (number): Rows to return (default 50, max 5000).
- `since` (string): Earliest inspection end date, YYYY-MM-DD.
- `state` (string): US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
- `until` (string): Latest inspection end date, YYYY-MM-DD.

### `fda_compliance_actions` (~255 tokens)

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).

Input parameters:

- `_apiKey` (string): 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_type` (string): Action type substring, e.g. "Warning Letter".
- `country` (string): Country name.
- `firm` (string): Firm legal-name substring.
- `fiscal_year` (string): FDA fiscal year.
- `limit` (number): Rows to return (default 50, max 5000).
- `product_type` (string): e.g. "Drugs", "Devices".
- `since` (string): Earliest action date, YYYY-MM-DD.
- `state` (string): US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
- `until` (string): Latest action date, YYYY-MM-DD.

### `fda_import_refusals` (~245 tokens)

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).

Input parameters:

- `_apiKey` (string): FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
- `country` (string): Country of origin, e.g. "India".
- `firm` (string): Firm name substring (this resource keys on FirmName).
- `limit` (number): Rows to return (default 50, max 5000).
- `product` (string): Product-code description substring, e.g. "Antibiotic".
- `since` (string): Earliest refusal date, YYYY-MM-DD.
- `state` (string): US state, as a postal code ("NJ") or full name ("New Jersey") — both work. Foreign sites carry no state; filter those by country.
- `until` (string): Latest refusal date, YYYY-MM-DD.

### `fda_firm_risk_profile` (~199 tokens)

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.

Input parameters:

- `_apiKey` (string): FDA Data Dashboard credential as "email:key" — the e-mail the credential was issued to, then the FDA-generated key, joined by a colon.
- `firm` (string, required): Firm name substring, e.g. "Intas".
- `limit` (number): Rows to scan per source (default 200, max 5000).
- `since` (string): Only count events on/after this date, YYYY-MM-DD.

## Diagnostics

Captured diagnostic sections: Provenance, Dependencies. The full working is on the page: https://verifymcp.io/servers/pipeworx-io-fda-inspections/pipeworx-mcp-fda-inspections#diagnostics

## Score history

- 2026-11-05: 81
- 2026-11-04: 81
- 2026-11-03: 80
- 2026-11-02: 80
- 2026-11-01: 79
- 2026-10-31: 78
- 2026-10-30: 78
- 2026-10-29: 78

## 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.

## Links

- npm package: https://www.npmjs.com/package/@pipeworx/mcp-fda-inspections
- Socket report: https://socket.dev/npm/package/@pipeworx/mcp-fda-inspections
- Repository: https://github.com/pipeworx-io/mcp-fda-inspections
- Website: https://pipeworx.io/packs/fda-inspections
- Changelog RSS feed: https://verifymcp.io/servers/pipeworx-io-fda-inspections/pipeworx-mcp-fda-inspections.xml
- Changelog JSON feed: https://verifymcp.io/servers/pipeworx-io-fda-inspections/pipeworx-mcp-fda-inspections.json
- HTML version of this page: https://verifymcp.io/servers/pipeworx-io-fda-inspections/pipeworx-mcp-fda-inspections