FDA records by company

Search the company in the directory or type its name into the free CDMO FDA inspection lookup. Each company page lists the inspection classifications, warning letters and recalls FDA has published that name it, and each record page states what FDA published with a link to the agency's own posting. Approve Suite reads FDA's warning-letter listing every six hours, the inspection Data Dashboard daily and the enforcement reports every six hours.

A classification is FDA's rating of one inspection: NAI (no action indicated), VAI (voluntary action indicated) or OAI (official action indicated). A warning letter is a separate step FDA can take after an OAI inspection, or on other evidence: a formal notice that the agency found significant violations and expects a written response, normally within 15 working days. Most inspections end without a letter; a letter usually follows an OAI.

FDA posts an inspection's classification on its Data Dashboard only after its review of the inspection is complete, which is typically a few months after the inspection ended and can be longer. Warning letters are posted to FDA's listing in weekly batches, usually within a few weeks of the letter's date. Recalls appear in the weekly enforcement report, one to three weeks after the firm began the recall.

No. FDA does not publish most Form 483s; they reach the public through a Freedom of Information Act request or when a company discloses one. These pages show what FDA publishes: the inspection's classification, the CFR sections cited where the Data Dashboard lists them, and any warning letter that follows.

No. Approve Suite is an independent product that reads records FDA publishes and links to each one. It is not affiliated with, endorsed by or operated on behalf of FDA, and nothing here is regulatory, legal or medical advice.