The FDA MCP server for Claude and ChatGPT.
Ask Claude or ChatGPT what FDA cited at a supplier’s last three inspections, or which 21 CFR sections your investigator writes up most. The answer comes back with the 483s and letters linked.
- a month, billed yearly
- From $78
- requests a month on Standard
- 10,000
- Claude, ChatGPT and other AI tools
- MCP
- read-only tools
- 27
What the subscription covers
FDA inspection data plus every Form 483, EIR and letter we have read, tagged and linked to its site, investigator and regulation.
- Inspections and outcomes
- 483 observation previews
- 21 CFR citations
- Investigators
- Warning letters
- Import alerts
- Recalls
- Registrations
- 510(k), PMA and NDC
A site's whole FDA history
Every inspection, classification, warning letter and most-cited regulation for a firm or FEI number.
Example Pharma, Inc.
Exampleville, NJ · FEI 3001234567
Cited most
- 211.192Production record review
- 211.67Equipment cleaning
- 211.100Written procedures
Investigator records
What each FDA investigator cites most and how long their inspections run.
Every observation
Search 483 observations and warning-letter violations by wording or 21 CFR section.
Every document, summarised
For each Form 483, EIR and warning letter: the summary, every extracted field, the opening words of each observation and its link on FDA Intel, so you can check the source yourself.
Regulation trends
How often FDA cites a section, and at which sites.
Ask it like a colleague
Pick a question to see the tools it calls and the answer it gives.
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
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
Find warning letters citing data integrity at oral solid dose sites in India since 2023 and summarize the violations.
Data-integrity warning letters, India, since 2023
- Most letters cite incomplete laboratory records (21 CFR 211.194) and audit trails that were off.
- Several follow a Form 483 with the same finding, classified OAI.
- Each letter's violations, FDA requests and close-out status are listed.
Warning letter
Aug 2023 · 3 violations
Warning letter
May 2024 · 5 violations
Form 483
Jan 2024 · 7 observations
Two plans. Billed yearly or monthly.
The same data in both, with Claude, ChatGPT and the API. They differ by requests a month and people. 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.
Connected in three steps
- 1Choose a planCreate your FDA Intel account and start Standard or Premium. Your account page shows the connector address.
- 2Add the connectorIn Claude, connect FDA Intel from the connector directory. In ChatGPT, add the address as a custom connector. Then sign in.
- 3AskAsk about a site, an investigator or a regulation. Answers cite the documents.
Available in Claude's connector directory
Prefer a REST API? See the API and its documentation.
- OAuth sign-inYou sign in to FDA Intel in a browser window. No key is pasted into a chat.
- Read-onlyThe assistant can search and read. It cannot change anything.
- Per-person accessEach person signs in with their own account. Disconnect an app or revoke a key at any time.
Questions, answered
What is an MCP server?
MCP (Model Context Protocol) is an open standard that lets AI assistants such as Claude and ChatGPT call outside tools. The FDA Intel MCP server gives the assistant read-only tools to search and read FDA inspection documents.
Is there an FDA MCP server for inspection data?
Yes. FDA Intel offers an MCP connector for FDA inspection documents: Form 483s, EIRs, warning letters, close-out letters and responses, with the firms, FEI numbers, investigators and regulations linked to them. Plans start at $89 a month.
Which AI assistants does it work with?
Claude, from Claude's connector directory; ChatGPT, through its custom connector feature; and any MCP client that supports remote servers: Claude Code, Cursor, VS Code and others, with OAuth sign-in or an API key.
What can I ask it?
Anything about a site's FDA record: its last inspection and outcome, warning letters and whether they were closed out, import alerts, recalls, registrations, past 483s, what an investigator cites most, which regulations FDA cites for a product type. Each document comes with its summary, the opening words of each observation and its link on FDA Intel.
How is this different from asking the assistant without it?
Without the connector, an assistant answers from its training data and general web results. With it, the assistant reads the actual Form 483s, EIRs and letters in the FDA Intel catalog and can point to the documents behind each answer.
Can the assistant change anything?
No. Every tool is read-only. It can search and read; it cannot add, edit or delete anything.
Do I need an FDA Intel account?
Yes. You sign in with your FDA Intel account when you add the connector, and the account needs a Standard or Premium plan. You can create the account and start a plan in a few minutes.
Is the full text of every document included?
No. The plans cover data: FDA public data, document metadata and summaries, profiles and the opening words of each observation. Full documents are bought and downloaded separately on the site; the connector does not deliver document text or PDFs. Need full document text at scale (thousands of documents) through an API? Talk to us.
What counts as a request?
One request is one tool call in Claude or ChatGPT, or one API call. Usage resets every month. Standard includes 10,000 requests a month (up to 1,000 a day); Premium 50,000 requests a month (up to 5,000 a day). Your account page shows a live usage meter, and every API reply carries the remaining count. A top-up adds 10,000 requests for $29, one time. Unused top-up requests end with the current monthly allowance period.
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.
What data does the subscription cover?
FDA inspection data (inspections and their outcomes, 483 citations, warning letters, import alerts, and recalls) plus our document intelligence: the Form 483s, EIRs and letters read, tagged and linked to the right firm, site, investigator and regulation.
Is there a REST API as well?
Yes. The same tools are a REST API for your own systems, included in both plans, with a full reference and an OpenAPI spec. See the API page.
What is the MCP server address?
Your account page shows it once you have a plan. The server follows the MCP authorization spec (OAuth 2.1 with dynamic client registration and PKCE), so ChatGPT and other clients only need the address; you sign in to FDA Intel in a browser window. In Claude you don't need the address: connect FDA Intel from Claude's connector directory.
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.