The FDA MCP server, in any client.
One address gives Claude Code, Cursor, VS Code and your own agents read-only tools over FDA inspection data: 483s, warning letters, investigators, import alerts and recalls.
claude mcp add --transport http fda-intel https://fdaintel.ai/mcpSet up in three steps
Your account page shows the server address once you have a plan.
- 1Choose a planCreate an FDA Intel account and start Standard or Premium.
- 2Add the serverPaste the address into your client, or run the one-line command above.
- 3Sign in onceApprove read-only access in the browser window, or send an API key instead.
27 read-only tools
The same tools as the REST API, with the same names and parameters.
Inspection documents
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 investigators
Site profiles by firm id or FEI, and FDA investigator profiles with what each one cites most.
Regulations and catalog
21 CFR sections with how often FDA cites them, filter values and catalog totals.
FDA public data
Inspections and citations, warning-letter status, import alerts, recalls, drug shortages, registrations, 510(k), PMA, NDC, drug applications and debarment.
- OAuth 2.1 and PKCEDiscovery, dynamic client registration and S256 PKCE, as the MCP spec asks.
- Read-onlyEvery tool is marked readOnlyHint. Nothing can be changed.
- Per-person accessEach person signs in with their own account. Revoke an app or key at any time.
Questions, answered
What is the FDA Intel MCP server?
A remote Model Context Protocol server that gives AI assistants and agents read-only tools over FDA inspection data: the FDA Intel catalog of Form 483s, EIRs, warning letters and responses (metadata, summaries, observation previews, profiles) and FDA public data on inspections, warning letters, import alerts, recalls, shortages, registrations and approvals.
Which clients work?
Any MCP client that supports remote servers over Streamable HTTP: Claude (web, desktop, mobile and Claude Code), ChatGPT, Cursor, VS Code, and agent frameworks with an MCP client. Clients that support OAuth only need the address; others can send an API key in the Authorization header.
How does sign-in work?
The server follows the MCP authorization specification: OAuth 2.1 with dynamic client registration and PKCE (S256). Your client opens a browser window, you sign in to FDA Intel and approve read-only access. Personal API keys from your account page work as Bearer tokens too.
Is there a local (stdio) version?
The server runs remotely, so there is nothing to install. For a client that only runs local servers, use a small stdio bridge that forwards to the remote address with your API key.
Can the tools change anything?
No. Every tool is read-only and marked with readOnlyHint, so clients can run them without asking each time.
How much does it cost?
Standard is $78/month on the annual plan (billed yearly as $935) or $89/month billed monthly, for 1 user and 10,000 requests a month (up to 1,000 a day); Premium is $218/month on the annual plan (billed yearly as $2,615) or $249/month billed monthly, for up to 3 users and 50,000 requests a month (up to 5,000 a day). Yearly billing saves about 12%. Both plans are flat prices for the same data and include Claude, ChatGPT and the API. On yearly billing the requests are still a monthly allowance: it resets every month of the year, on the same day of the month as your start date. A top-up adds 10,000 requests for $29, one time. Unused top-up requests end with the current monthly allowance period. Documents are bought separately. Enterprise, larger teams or bulk data: talk to us.
Prefer a REST API? See the API and its documentation.
Claude is a trademark of Anthropic. ChatGPT is a trademark of OpenAI. FDA Intel is independent and not affiliated with or endorsed by either company, or by the U.S. Food and Drug Administration.