fda-mcp-server

FDA compliance intelligence tools for Claude, Cursor, and any MCP client. Query recalls, adverse events, warning letters, and CSA risk data directly from your AI assistant.

No API key required for free tools. Subscribe for enriched CSA analysis.

What You Can Do

Free — ask Claude things like:

• "Find Class I device recalls from Medtronic"
• "Show me adverse events for Philips ventilators"
• "Pull up the enforcement profile for Exactech"

Pro ($49/mo) — enriched dataset:

• "Run a CSA risk assessment on Fresenius Kabi"
• "Generate a supplier qualification report for Baxter International"
• "Analyze citation patterns for CFR Part 820"

Tools

Free (live openFDA data)

| Tool | What it does | |------|-------------| | search_recalls | Search recalls by product type, classification, firm, state, or date range | | search_device_events | Search MAUDE adverse events by manufacturer, brand, event type, or date | | company_enforcement_profile | Recalls + adverse events (+ warning letters and 483s with Pro key) |

Pro (enriched CSA dataset, API key required)

| Tool | What it does | |------|-------------| | csa_risk_assessment | Risk score with 4.2x escalation multiplier, failure modes, citation breakdown | | citation_analysis | Citation patterns by CFR part, section, and category with CSA percentages | | supplier_qualification_report | Audit-ready qualification brief with risk level and recommendation |

The enriched tools are powered by 1,047 classified warning letters, 6,714 Form 483 observations, 3,600+ extracted citations, and 157 failure modes — all classified for CSA relevance across the QSR-to-QMSR regulatory transition.

Setup

Free (local, no account needed)

Runs locally via npx. No API key, no account, no server.

Claude Desktop — add to Settings > Developer > Edit Config:

{
  "mcpServers": {
    "fda": {
      "command": "npx",
      "args": ["-y", "fda-mcp-server"]
    }
  }
}

Claude Code:

claude mcp add fda -- npx -y fda-mcp-server

Restart your client. You should see search_recalls, search_device_events, and company_enforcement_profile.

Pro (hosted, all 6 tools)

Get an API key at fda-csa-intel.jasencarroll.com. Pro connects to the hosted server over HTTP — no npm install needed.

Claude Desktop — add to Settings > Developer > Edit Config:

{
  "mcpServers": {
    "fda": {
      "type": "streamable-http",
      "url": "https://fda-mcp-server.jasencarroll.com/mcp",
      "headers": {
        "Authorization": "Bearer fda_live_your-key-here"
      }
    }
  }
}

Claude Code:

claude mcp add fda --transport http https://fda-mcp-server.jasencarroll.com/mcp --header "Authorization: Bearer fda_live_your-key-here"

Any MCP client

The server supports two transports:

• stdio (free tools): npx fda-mcp-server — standard MCP stdio transport
• HTTP (all tools): POST https://fda-mcp-server.jasencarroll.com/mcp — Streamable HTTP transport with Authorization: Bearer header

Data Sources

Free tools use live public data from the openFDA API (recalls, adverse events). No authentication required.

Pro tools query a curated PostgreSQL database classifying FDA warning letters and 483 observations for CSA relevance based on CFR citations (21 CFR 211.68, 820.70(i), Part 11) and narrative analysis. Dataset maintained at fda_platform.

Self-Hosting

Run enriched tools against your own database instead of using an API key:

{
  "mcpServers": {
    "fda": {
      "command": "npx",
      "args": ["-y", "fda-mcp-server"],
      "env": {
        "DATABASE_URL": "postgresql://localhost:5432/fda_platform"
      }
    }
  }
}

See fda_platform for the database dump and restore instructions.

License

MIT

Author

Jasen Carroll — Quality engineering + software, FDA-regulated industries.

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