An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer

A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.  This means that if your drug manufacturing facility is inspected, it is nearly twice as likely as before that FDA will follow up with regulatory or enforcement action, which can include Warning Letters, freezes on drug approval applications or on issuing export certifications, requests for a recall, seizures, or requests for consent decrees.

The analysis was prepared for Pharma Conference’s conference on February 8 and 9 in San Diego (“Current Hot GMP Topics”), linked here, where Hyman, Phelps & McNamara, P.C., Director Doug Farquhar will be presenting on three areas: enforcement areas of primary concern, the conduct of internal investigations, and contacting FDA about inspections.  Other speakers at the conference include Alonza Cruse, the Director of the Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs; several prominent drug manufacturing consultants with significant FDA experience; and attorney Jennifer Bragg, an attorney formerly at FDA and now a nationally recognized lawyer advising FDA-regulated companies facing government investigations and related enforcement challenges.

Mr. Farquhar will be presenting the results of research on FDA’s inspection database which he and HPM Legal Assistant Aisha Evans conducted.  The analysis shows, predictably, that FDA inspections of drug manufacturing facilities dropped precipitously during the first two years of COVID, but are gradually ramping up again, consistent with FDA’s predictions (see August 2022 blogpost linked here).  The chart below shows the number of inspections per fiscal year (FY) (which runs from October 1 through September 30).  FDA, Inspections Database (last visited Jan. 29, 2023).

*Legal Assistant/Paralegal