The FDA connector for ChatGPT.
Connect FDA Intel and ChatGPT reads Form 483s, EIRs and warning letters in chat and in deep research, citing each document.
Set up in ChatGPT
A few minutes, once. After that FDA Intel is one of its tools.
- 1Choose a planCreate your FDA Intel account and start Standard or Premium. Your account page shows the connector address.
- 2Add the connectorIn ChatGPT settings, add a custom connector with that address (developer mode, or your workspace admin on business plans).
- 3Connect and askSign in to FDA Intel, approve read-only access, then select it in a chat or in deep research.
Try these in ChatGPT
The firm, FEI and investigator names are made up. Use your own.
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
Prepare me for an FDA inspection at Example Pharma (FEI 3001234567) next month.
Pre-inspection brief: Example Pharma, Exampleville, NJ
- Last three inspections: two VAI, one NAI. The March 2024 Form 483 had 6 observations.
- Repeat theme: production record review (21 CFR 211.192), cited in 2021 and 2024.
- Likely investigator J. Example cites 211.192 and 211.67 most; inspections run about 8 days.
Form 483
Mar 2024 · 6 observations
EIR
Mar 2024 · 42 pages
J. Example
Investigator profile
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
- OAuth sign-inYou sign in to FDA Intel in a browser window. No key is pasted into a chat.
- Read-onlyChatGPT 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 ChatGPT. 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
Is there an FDA connector for ChatGPT?
Yes. FDA Intel offers an MCP connector that lets ChatGPT search and read FDA inspection documents (Form 483s, EIRs, warning letters, close-out letters and responses) and the firm, investigator and regulation records linked to them. Plans start at $78 a month on the annual plan.
Does it work with ChatGPT deep research?
Yes. The connector provides the search and fetch tools that deep research uses, so a research report can draw on document summaries, observation previews and FDA public data, and cite them.
Which ChatGPT plans can add custom connectors?
OpenAI decides which plans can add custom connectors and how. On business and enterprise workspaces an admin usually adds the connector first; members then sign in to FDA Intel themselves.
Can ChatGPT read the whole document?
No. It 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.