FDA Intel

Getting started

FDA Intel developer docs

FDA inspection intelligence for AI assistants and your own code: Form 483s, EIRs, warning letters, FDA investigators and 21 CFR citations, plus FDA public data on inspections, import alerts, recalls and registrations. 27 read-only tools, two simple plans.

Choose how to connect#

Both ways use the same tools, the same data and the same plan allowance. Pick by who is asking the questions.

Connect your AI (MCP)For people. Claude, ChatGPT and other AI assistants call FDA Intel's tools while you chat, and answer with the documents linked. You sign in once in a browser window (OAuth); there is no code to write.Set up Claude, ChatGPT or another client Call the REST APIFor software. Your scripts, dashboards and data pipelines send GET requests with an API key and get JSON back. Same tools, as HTTP endpoints, with an OpenAPI spec.Make your first API call
Who uses itMCP: AI assistants: Claude, ChatGPT, Claude Code, Cursor, VS Code, agentsREST: Your code: scripts, internal tools, BI and data pipelines
Sign-inMCP: OAuth in a browser window (or an API key header)REST: An API key from your account page, as a Bearer token
AddressMCP: https://fdaintel.ai/mcpREST: https://fdaintel.ai/api/intel/v1
You getMCP: Answers in chat, with the documents linkedREST: JSON you can store, join and chart

Addresses#

MCP server
https://fdaintel.ai/mcp
REST API base URL
https://fdaintel.ai/api/intel/v1
OpenAPI 3.1 spec
https://fdaintel.ai/api/openapi.json
MCP server card
https://fdaintel.ai/.well-known/mcp.json
OAuth metadata
https://fdaintel.ai/.well-known/oauth-protected-resource/mcp

Before you start#

You need an FDA Intel account with a Standard or Premium plan (from $78/month, billed yearly): compare plans, then start one on your account page. The same page shows your MCP address, creates API keys and shows live usage.

Your first call#

A site's current FDA standing by FEI number, over REST. In an AI assistant, ask "What is the FDA standing of FEI 3001234567?" and it calls the same tool.

curl "https://fdaintel.ai/api/intel/v1/call/facility_signal?fei=3001234567" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"

What the tools cover#

Inspection documents5 tools · Form 483s, EIRs, warning letters, responses and close-out letters in the FDA Intel catalog: search, metadata, summaries and observation previews, with each document's link on FDA Intel.Firms and investigators4 tools · Site profiles by firm id or FEI, and FDA investigator profiles with what each one cites most.Regulations and catalog4 tools · 21 CFR sections with how often FDA cites them, filter values and catalog totals.FDA public data14 tools · Inspections and citations, warning-letter status, import alerts, recalls, drug shortages, registrations, 510(k), PMA, NDC, drug applications and debarment.

Every tool is read-only. Plans cover data: metadata, summaries, profiles, citations and the opening words of each observation, with each document's link. Document text and PDFs are not part of the API; full documents are bought and downloaded on the site.