FDA suspends most inspections of foreign drug, device and food manufacturers

FDA Commissioner Stephen Hahn said in a statement that the decision was based on State Department travel advisories, Centers for Disease Control and Prevention travel recommendations and restrictions imposed on foreign visitors by certain countries. He added the agency will “maintain oversight over international manufacturers and imported products using alternative tools and methods.”

The postponement is likely to increase concerns about the U.S. reliance on drugs and ingredients made abroad and about possible shortages due to the novel coronavirus. Not only are many medications used in the United States manufactured overseas, but critical ingredients — and the chemicals used to make them — also are overwhelmingly made in China and other countries. Last month, the FDA said one drug is in short supply due to the virus, but it declined to say which one.

The agency says it will rely more heavily on other tools, such as denying entry of unsafe products into the United States, using information supplied by foreign governments and requesting company records.

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