FDA warning letter search
A warning letter is FDA's formal notice that a firm has significant violations. RegDataLab indexes FDA warning letters with their dates, issuing office and, where captured, the letter text, and links each one to the company and facility it names.
No key needed for the check. For the full record, connect RegDataLab or use the API.
What you can look up
Letters by company
Search by company name, including parents and subsidiaries resolved to one company family.
Letter text and excerpts
The letter index runs from about 2021, with body text for letters where it was captured. Older letters appear as compliance actions.
Seizures and injunctions
Warning letters sit alongside the other serious compliance actions FDA reports, such as seizures and injunctions.
Untitled promotional letters
OPDP untitled letters cover drug promotion issues that stop short of a warning letter.
Ask it in Claude or ChatGPT
- List every FDA warning letter sent to [company] and its subsidiaries.
- Find recent warning letters that cite aseptic processing problems.
- Did [supplier] get a warning letter after its last OAI inspection?
50 credits now, 300 credits a month once you verify your email.
Questions
- What is an FDA warning letter?
- A warning letter is FDA's formal notice to a firm that it has significant violations of FDA rules. It usually asks for a written response within 15 working days.
- Why do warning letter totals look so high?
- Most compliance actions FDA reports are tobacco retailer letters from the Center for Tobacco Products. Search by company or facility to see one manufacturer's letters, or use the research page for the count of warning letters outside tobacco.
- Is there a warning letter API?
- Yes. Every search on this page is available over HTTPS with an API key, and the same calls work as tools in Claude, ChatGPT and other MCP clients.
- How do I use RegDataLab in Claude or ChatGPT?
- Add https://www.regdatalab.com/mcp as a custom connector (Claude: Customize, Connectors, Add custom connector; ChatGPT: add a custom MCP server with OAuth), sign in with your key, then ask in plain English. 50 credits now, 300 credits a month once you verify your email.
- Is RegDataLab part of the FDA?
- No. RegDataLab is an independent data product built on public FDA records. It is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration.
Related searches