FDA 483 search
A Form 483 lists the objectionable conditions an FDA investigator observed during an inspection. RegDataLab ties the inspection citations FDA releases, with their CFR sections, and the Form 483 documents FDA posts in its reading room to the company and facility (FEI) they belong to, so you can search them by name instead of by PDF.
No key needed for the check. For the full record, connect RegDataLab or use the API.
What you can look up
Citations by company and site
Every inspection citation FDA releases, with the CFR section, the short observation text and the inspection date, matched to the facility's FEI.
Published Form 483 documents
Form 483s and other inspection records from FDA's reading room, with the document text where FDA publishes it machine-readable.
The inspection outcome
Each citation sits next to the inspection it came from and its classification: NAI, VAI or OAI.
Patterns across an industry
FDA's annual observation summaries show which citations come up most often, so one supplier's 483 can be read against the norm.
Ask it in Claude or ChatGPT
- Show the Form 483 citations for [company] since 2022, grouped by facility.
- Which 21 CFR 211 sections were cited most often at [company]'s sites?
- Find the latest published Form 483 for FEI [number] and summarize the observations.
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Questions
- What is an FDA Form 483?
- Form FDA 483, Inspectional Observations, is handed to a firm at the end of an inspection when the investigator saw conditions that may violate FDA rules. It is not a final agency decision; a warning letter is FDA's formal enforcement notice.
- Does FDA publish every Form 483?
- No. FDA releases inspection citations through its data dashboard and posts selected Form 483 documents in its reading room. RegDataLab searches both and shows which source each record came from.
- Can I search 483s by company name?
- Yes. RegDataLab resolves a company name to its facilities and FEI numbers, so a search for one company returns the citations from each of its sites.
- 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.
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