FDA inspection data in Claude.
Connect FDA Intel to Claude and ask about any FDA-inspected site, investigator or 21 CFR section. Answers come with the Form 483s and letters linked.
Set up in Claude
A few minutes, once. After that FDA Intel is one of its tools.
- 1Find FDA IntelOpen FDA Intel in Claude's connector directory, or in Claude go to Customize → Connectors → Browse and search "FDA Intel".
- 2Click ConnectWorks in claude.ai, Claude Desktop, the mobile apps and Cowork: one catalog, connect once.
- 3Sign in and allowSign in to FDA Intel and click Allow. An active Standard or Premium plan is needed: see plans.
Other ways to connect
Add it as a custom connector. In Claude open Settings → Connectors, click Add custom connector and paste https://fdaintel.ai/mcp. Then click Connect, sign in to FDA Intel and click Allow. On Team and Enterprise plans an owner may need to add it first.
Claude Code. Run claude mcp add --transport http fda-intel https://fdaintel.ai/mcp, then type /mcp to sign in. Step by step.
Other MCP clients. Cursor, VS Code and any client that supports remote MCP servers: setup for MCP clients.
Try these in Claude
The firm, FEI and investigator names are made up. Use your own.
What does investigator J. Example focus on? Which CFR sections does she cite most, and how long do her inspections run?
J. Example: FDA investigator profile
- Named on 48 Form 483s and EIRs, mostly at drug sites in New Jersey and Pennsylvania.
- Cites 21 CFR 211.192 most, then 211.67 and 211.100.
- Inspections average 7 days; about one in five ends OAI.
J. Example
Investigator profile
21 CFR 211.192
Cited most
Form 483
Mar 2024 · 6 observations
Which 21 CFR 211 sections were cited most in sterile drug 483s in 2023 and 2024? Quote a typical observation for the top one.
Most-cited sections, sterile drug 483s, 2023–2024
- 211.113 (microbiological contamination) leads, followed by 211.42 and 211.192.
- Typical wording: “Procedures designed to prevent microbiological contamination … are not followed.”
- Each observation links back to its Form 483 and site.
21 CFR 211.113
Top section
Form 483
Nov 2023 · 9 observations
Form 483
Apr 2024 · 5 observations
Give me the FDA record of our API supplier Example Chem Ltd. Any OAI, warning letters or repeat observations since 2020?
Example Chem Ltd., Hyderabad: FDA record since 2020
- The 2022 inspection was classified OAI; a warning letter followed in February 2023.
- Repeat observation: laboratory controls (21 CFR 211.160), cited in 2020 and 2022.
- FDA issued a close-out letter in 2025.
Form 483
Jun 2022 · 8 observations
Warning letter
Feb 2023 · 4 violations
Close-out letter
2025
- OAuth sign-inYou sign in to FDA Intel in a browser window. No key is pasted into a chat.
- Read-onlyClaude can search and read. It cannot change anything.
- Per-person accessEach person signs in with their own account. Disconnect the app at any time.
Plans
An active Standard or Premium plan connects FDA Intel to Claude. Yearly billing saves 12%.
Standard
1 user$78/month
On the annual plan, billed yearly as $935Save 12%
FDA inspection data and document search for one person.
- Inspections and outcomes, 21 CFR citations, warning letters, import alerts, recalls, registrations and approvals
- Firm, site and investigator profiles, document search and observation previews
- In Claude, ChatGPT and through the API
10,000 requests a month (up to 1,000 a day).
Start Standard, yearlyPremium
Up to 3 users$218/month
On the annual plan, billed yearly as $2,615Save 12%
The same data for a small team, with five times the requests.
- Everything in Standard
- Up to 3 people on one subscription
- Five times the requests
50,000 requests a month (up to 5,000 a day).
Start Premium, yearlyEnterprise, larger teams or bulk data: talk to us.
One request is one tool call in Claude or ChatGPT, or one API call. Usage resets every month. 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.
The plans cover data, summaries and observation previews. Full documents are bought and downloaded separately on the site.
Need full document text at scale (thousands of documents) through an API? Talk to us.
Cancel any time in Account → AI & API: Cancel plan keeps access until the end of the period you paid for, or use Manage billing (the Creem billing portal). Removing the connector from Claude or ChatGPT does not cancel the subscription.
Questions, answered
How do I get FDA data in Claude?
Connect FDA Intel from Claude's connector directory (Customize, then Connectors, then Browse, and search "FDA Intel"). Claude then searches and reads FDA inspection documents (Form 483s, EIRs, warning letters, responses) through FDA Intel's read-only tools when you ask about a site, an investigator or a regulation.
Is FDA Intel in Claude's connector directory?
Yes. FDA Intel is listed in Claude's connector directory, so you connect it with one click in claude.ai, Claude Desktop, the mobile apps and Cowork. On Team and Enterprise plans an organization owner may need to allow it first; members then connect with their own FDA Intel sign-in. You can also add the address as a custom connector.
Does it work in Claude Code or the Claude desktop app?
Yes. The connector is a remote MCP server with OAuth sign-in, so it works in the Claude apps on web, desktop and mobile and in Claude Code (claude mcp add --transport http fda-intel <address>).
Can Claude read the whole document?
No. Claude reads the summary, every extracted field and the opening words of each observation, and gives you the document's link on FDA Intel, where the full document can be bought and downloaded. Document text and PDFs are not delivered through the connector.
Is my FDA Intel account safe?
You sign in with OAuth, so no key is pasted into a chat. The tools are read-only, and access can be revoked at any 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.
How do I cancel?
Cancel any time in Account → AI & API: Cancel plan keeps access until the end of the period you paid for, or use Manage billing (the Creem billing portal). Removing the connector from Claude or ChatGPT does not cancel the subscription.
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.