CDMO FDA inspection lookup

Type the contract manufacturer's name into the box above. The lookup searches the inspection classifications, warning letters and recalls FDA has published and shows every record that names the company, newest first, with the outcome of each inspection and a link to the record. It is free and needs no account. For history older than the records held here, FDA's Data Dashboard lists classified inspections back to 2009.

They are FDA's three inspection classifications. NAI, no action indicated: no objectionable conditions were found, or none that justify further action. VAI, voluntary action indicated: objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action. OAI, official action indicated: regulatory or administrative action is recommended, which can lead to a warning letter, an import alert or a consent decree.

From FDA's own publications: inspection classifications from the FDA Data Dashboard, warning letters from FDA's warning-letter listing, and recalls from FDA's weekly enforcement reports through openFDA. Each record on the result links to the agency's own page. Nothing is scraped from a company's website or typed in by hand.

FDA posts a classification only after its review of the inspection is complete, which is typically a few months after the inspection ended, and some inspections are never posted. The lookup shows what FDA has published, so an inspection that closed last month is usually not on the dashboard yet. A Form 483 is not published either; it reaches the public through a FOIA request, or when the company discloses it.

No. FDA does not publish most Form 483s. The lookup shows what is public: the inspection's classification, the CFR sections FDA cited where the dashboard lists them, and any warning letter that followed. A free account on the full product adds the cited sections on each inspection record.

Yes. Approve Suite Pro ($79 a month or $790 a year) lets you name the CDMOs, sites and biotechs you follow and emails you when FDA posts an inspection classification, warning letter or recall for any of them, with the record linked. A free account shows every record for the last 7 days. No card and no sales call.

No. An inspection outcome says what FDA found on one visit to one site, at one point in time. Every result links to FDA's own record, so you can read what it says.