Check a CDMO's FDA history
To check a CDMO's FDA inspection and warning letter history before signing, look up each manufacturing site by its FEI number, not just the company name. Read the inspection outcomes (NAI, VAI or OAI), the Form 483 observations, any warning letters and import alerts, and the recalls traced to that site. FDA publishes all of this, but across separate databases. RegDataLab joins them by company and site, so one question in Claude or ChatGPT, or one free check below, returns the full record with fda.gov links.
No key needed for the check. For the full record, connect RegDataLab or use the API.
What to check before you sign
1. The exact sites that will make your product
A CDMO's record is site by site. Ask for the FEI number of each facility in the contract and check those, plus the parent company and any names the site used before an acquisition.
2. Inspection outcomes
For each site: when FDA last inspected it and how each inspection was classified. OAI means regulatory or administrative action was recommended. A run of VAI results with repeat findings is worth a question too.
3. Form 483 observations
The 21 CFR sections cited at each inspection and the Form 483 documents FDA has posted. Look for the same observation coming back, and for findings in the area you are buying: sterile filling, lab controls, data integrity.
4. Warning letters
Warning letters addressed to the site or its parent, with the letter text and date. A warning letter is FDA's formal enforcement notice and can hold up approvals that name the site.
5. Import alerts and refusals
For sites outside the United States: whether the firm is on an FDA import alert, and whether its shipments have been refused entry.
6. Recalls traced to the site
Recalls of products the facility made, including recalls announced under a customer's name.
Ask it in Claude or ChatGPT
- We are about to sign with [CDMO]. Check the FDA record for its [city] site: inspections, Form 483 observations, warning letters and import alerts since 2020.
- Compare [CDMO A], [CDMO B] and [CDMO C] on FDA inspection outcomes and warning letters for their sterile sites.
- Has FEI [number] had an OAI inspection or a repeat Form 483 observation in the last five years?
50 credits now, 300 credits a month once you verify your email.
Questions
- How do I check a CDMO's FDA inspection and warning letter history before signing a contract?
- Get the FEI number of every site named in the contract. For each one, look up the inspection history and classifications in FDA's Data Dashboard, the Form 483s FDA has posted in its reading room, and warning letters on fda.gov. Check import alerts for foreign sites and recalls tied to the facility. RegDataLab returns all of these for a company or FEI in one answer, with links to the FDA source for each record.
- Where does FDA publish this information?
- In several places: the FDA Data Dashboard (inspection classifications and citations), the warning letters page on fda.gov, the Office of Inspections and Investigations reading room (selected Form 483s and inspection reports), the import alert list and the recall enforcement reports. Each uses its own company spellings, which is why a search by name alone can miss a site.
- What does it mean if a CDMO site has no FDA records?
- Only that no matching public record was found. The site may not have been inspected recently, may be registered under another name, or its Form 483 may not have been posted. Ask the CDMO for its last FDA inspection date, the Form 483 if one was issued, and its response.
- Is one Form 483 a reason to walk away?
- Not on its own. A Form 483 lists an investigator's observations and is not a final FDA decision. What matters is how serious the observations are, whether they repeat across inspections, and whether a warning letter or an OAI classification followed.
- Can I compare several CDMOs at once?
- Yes. The free compare tool puts two companies side by side, and in Claude or ChatGPT you can ask RegDataLab to compare a shortlist on inspections, Form 483 citations, warning letters, import alerts and recalls.
- 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: Plugins, Add, Add custom MCP server, Authentication 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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