Skip to Main Content

For companies readying medicines for regulatory approval, the Food and Drug Administration can take up to half a year to issue follow-up warning letters over problematic manufacturing facilities.

Last year, the median time it took the agency to issue a warning letter was 191 days, or slightly more than six months after closing an inspection and sending a so-called 483 form to a drug maker, according to a report released by the FDA.


While this may appear to be a long time, it nearly matches the six-month target set in a white paper the FDA released last June, according to Thomas Cosgrove, a partner at the Covington & Burling law firm, who is a former acting compliance director at the FDA division that approves drugs and former director of the FDA office of manufacturing quality.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!