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Home » BREAKING: FDA postponing all foreign inspections amid coronavirus outbreak

BREAKING: FDA postponing all foreign inspections amid coronavirus outbreak

March 10, 2020 By Chris Newmarker

FDAThe 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.

 

Filed Under: Featured, Regulatory/Compliance Tagged With: coronavirus, FDA

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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