FDA Halts Domestic Surveillance Inspections

Regulatory NewsRegulatory News | 18 March 2020 |  By 

The US Food and Drug Administration (FDA) said Wednesday that it has temporarily postponed all domestic routine surveillance facility inspections.

The decision, which FDA said is for "the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors" follows an attempt by an FDA official to inspect a contract development and manufacturing organization (CDMO) on Monday.

The CEO of the CDMO, who requested that he and his firm remain anonymous, explained to Focus via email on Tuesday 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 Commissioner Stephen Hahn said in a statement: "I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate."

Editor's note: Article updated on 18 March with FDA's announcement.


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