USA – FDA suspends routine domestic inspections

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.