MCP-ready FDA intelligence

Clean FDA data for AI agents

Stop wrestling with FDA data. FDA Data MCP unifies 5 disparate databases into one standard interface. Normalized, cross-referenced, and ready for your AI agent.

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Connect your agent

Claude Code — one command:

claude mcp add fda-data \
  --transport http \
  --header "Authorization: Bearer fda_demo_GKNDjUOjPbhLZZVPvRHDlY3zP_H3HXzTMRbHVD_I5rg" \
  https://www.regdatalab.com/mcp

MCP client config:

{
  "mcpServers": {
    "fda-data": {
      "url": "https://www.regdatalab.com/mcp",
      "headers": {
        "Authorization":
          "Bearer fda_demo_GKNDjUOjPbhLZZVPvRHDlY3zP_H3HXzTMRbHVD_I5rg"
      }
    }
  }
}

Demo key — 50 credits, no signup required. Get 1,000 free credits →

Who uses this

Use Cases

Regulatory Intelligence

Monitor competitors' inspection outcomes, warning letters, and enforcement actions across subsidiaries. Get the signal without manually cross-referencing five different FDA databases.

Due Diligence

Assess M&A targets in hours, not weeks. Pull facility histories, product approvals, recall exposure, and compliance signals into one risk profile — before the LOI goes out.

Quality & Compliance

Stay audit-ready. Track recall exposure across your supplier network, validate facility registration status, and prep for inspections with historical citation and compliance action data.

Why teams pick FDA Data MCP

Features

23 MCP Tools

Full coverage across facilities, enforcement actions, drug approvals, device clearances, inspections, citations, and veterinary data — all through one MCP endpoint.

Company Resolution

68,000+ company name normalizations baked in. We track the corporate family tree so you don't have to.

Cross-Referenced

Query a company → see all their facilities → check inspection history → find enforcement actions. Every dataset linked so your agent can follow the trail.

MCP Standard

Works with any MCP-compatible agent — Claude Desktop, custom pipelines, or your own tooling. Single HTTP endpoint, standard protocol.

Always Fresh

Data is ingested on FDA cadence: daily for enforcement, weekly for inspections, monthly for facility registration. Provenance metadata included on every response.

Credit-Based

Start free with 1,000 credits. Scale to Pro when you need higher throughput. No surprise bills — you always know exactly what you're using.

Quick start

API

1. Initialize MCP session

URL=https://www.regdatalab.com/mcp

curl -X POST $URL \
  -H "Authorization: Bearer $FDA_API_KEY" \
  -H "Content-Type: application/json" \
  -d '{
    "id": "init",
    "method": "initialize",
    "params": {
      "protocolVersion": "2024-11-05",
      "capabilities": {},
      "clientInfo": {
        "name": "agent",
        "version": "1.0"
      }
    }
  }'

2. Call a tool

curl -X POST $URL \
  -H "Authorization: Bearer $FDA_API_KEY" \
  -H "Mcp-Session-Id: <session>" \
  -H "Content-Type: application/json" \
  -d '{
    "id": "call",
    "method": "tools/call",
    "params": {
      "name": "fda_lookup_company",
      "arguments": {"company": "Pfizer"}
    }
  }'

Tooling coverage

23 tools
  • fda_lookup_company Full company profile with facilities, enforcement, and aliases.
  • fda_search_facilities Search facilities by name, location, or operations.
  • fda_get_facility Fetch full facility detail by FEI number.
  • fda_facility_products List products and approvals tied to a facility.
  • fda_search_enforcement Search drug + device recalls by company or class.
  • fda_resolve_company Resolve names to canonical company slugs and aliases.
  • fda_save_aliases Submit new alias mappings for review.
  • fda_suggest_subsidiaries Discover likely subsidiaries for a parent company.
  • fda_search_aphis Search APHIS inspections for veterinary facilities.
  • fda_search_510k Query 510(k) device clearances by product or sponsor.
  • fda_search_pma Explore PMA approvals with filtering by sponsor and date.
  • fda_search_drugs Search drug application approvals by sponsor and status.
  • fda_search_ndc Look up NDC listings and labeler data.
  • fda_search_by_product Find products across datasets by code or name.
  • fda_device_class Retrieve device class metadata and definitions.
  • fda_product_code_lookup Resolve FDA product codes to classifications.
  • fda_recall_facility_trace Trace recalls back to manufacturing facilities.
  • fda_inspections FDA Dashboard inspections with facility linkage.
  • fda_company_full Unified company profile across FDA datasets.
  • fda_citations FDA Dashboard citations and enforcement linkage.
  • fda_compliance_actions FDA Dashboard compliance actions across facilities.
  • fda_import_refusals FDA Dashboard import refusals and screening detail.
  • fda_ires_enforcement IRES enforcement actions with official FDA status fields.
Company & Facilities 8 tools
  • fda_lookup_company Full company profile with facilities, enforcement, and aliases.
  • fda_company_full Unified company profile across FDA datasets.
  • fda_resolve_company Resolve names to canonical company slugs and aliases.
  • fda_save_aliases Submit new alias mappings for review.
  • fda_suggest_subsidiaries Discover likely subsidiaries for a parent company.
  • fda_search_facilities Search facilities by name, location, or operations.
  • fda_get_facility Fetch full facility detail by FEI number.
  • fda_facility_products List products and approvals tied to a facility.
Enforcement & Compliance 7 tools
  • fda_search_enforcement Search drug + device recalls by company or class.
  • fda_recall_facility_trace Trace recalls back to manufacturing facilities.
  • fda_inspections FDA Dashboard inspections with facility linkage.
  • fda_citations FDA Dashboard citations and enforcement linkage.
  • fda_compliance_actions FDA Dashboard compliance actions across facilities.
  • fda_import_refusals FDA Dashboard import refusals and screening detail.
  • fda_ires_enforcement IRES enforcement actions with official FDA status fields.
Drugs 3 tools
  • fda_search_drugs Search drug application approvals by sponsor and status.
  • fda_search_ndc Look up NDC listings and labeler data.
  • fda_search_by_product Find products across datasets by code or name.
Devices 4 tools
  • fda_search_510k Query 510(k) device clearances by product or sponsor.
  • fda_search_pma Explore PMA approvals with filtering by sponsor and date.
  • fda_device_class Retrieve device class metadata and definitions.
  • fda_product_code_lookup Resolve FDA product codes to classifications.
Veterinary 1 tool
  • fda_search_aphis Search APHIS inspections for veterinary facilities.

Free resources

Open Data

FDA Recall Statistics 2026

Comprehensive recall data: total counts, Class I/II/III breakdowns, top companies, geographic distribution, and year-over-year trends. Updated daily from official FDA databases.

FDA Warning Letter & Compliance Statistics 2026

Warning letter volume, compliance action breakdowns, Form 483 observations, top cited companies, and CFR trends. Updated daily from FDA compliance databases.

FDA 510(k) Clearance Statistics 2026

510(k) clearance data: total decisions, decision code breakdowns, average review time, top companies, and most common product codes. Updated daily from FDA device clearance data.

FDA Inspection Statistics 2026

Facility inspection data: OAI/VAI/NAI outcomes, top inspected companies, geographic distribution, product types, and center activity. Updated daily from official FDA inspection dashboards.