The U.S. FDA said today that it is postponing foreign inspections through April as the coronavirus outbreak continues to worsen around the world.
The agency already halted medical device plant inspections in China, where the virus originated.
Dr. Stephen Hahn, the FDA’s commissioner, said in a statement that the agency came to its latest decision after taking into account guidance from the U.S. State Department, the Centers from Disease Control and Prevention, and the Office of Personnel Management.
“Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” Hahn said.
Alternatives to inspecting plants overseas include denying entry of unsafe products, physical examinations and/or product sampling at U.S. borders, reviewing a firm’s previous compliance history, information sharing with foreign governments, and requesting records “in advance of or in lieu of” on-site drug inspections, according to Hahn.
The FDA said it will evaluate any potentially mission-critical inspections outside the U.S. on a case-by-case basis.
