Contract manufacturer: FDA has halted domestic pharma inspections
The FDA appears to have halted its domestic inspections of pharmaceutical facilities, although not before attempting to inspect a contract development and manufacturing organization (CDMO) on Monday and subsequently deciding to end the inspection early and announce the halt.
The CEO of the CDMO, who requested that he and his firm remain anonymous, explained to Focus via email how his company received a last-minute inspection request from an FDA inspector whose planned trip for inspections in Europe was canceled.
Last Friday afternoon, the inspector allegedly called the CDMO to say he would be coming in for a post-approval inspection on two generic drugs. The CEO said he did not understand the need for the inspection as the site had received a pre-approval inspection and general inspection in January 2019, so the company did not expect another inspection for two or three years.
But the FDA inspector arrived alone on Monday morning, the CEO said, and the company firmly expressed its opposition to the inspection at that time as it could put himself and about 15 company employees at risk due to Covid-19. The CEO noted that there did not appear to be a need for the post-approval inspection of these generics as there were no in-market issues or complaints, nor was there a convincing need for a general systems inspection.
Nevertheless, the inspector performed the inspection for between two and three hours and then received a phone call to end the inspection, and he verbally told the CDMO that FDA is suspending all domestic inspections.
Another US-based CDMO that also sought to remain anonymous told Focus that it was contacted Monday about the need for a brief FDA visit on Tuesday, but that was subsequently canceled.
FDA has not responded to a request for comment on the halt to domestic inspections but this story will be updated when it does.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.