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

The agency said routine inspections will be halted through April in response to the coronavirus outbreak

The Food and Drug Administration is suspending most inspections of overseas manufacturers making drugs and other imports, the agency announced Tuesday. (Jacquelyn Martin/AP)

The Food and Drug Administration said Tuesday that it is postponing most inspections of foreign manufacturers of pharmaceutical products, medical devices and food imported into the United States. The inspections will be suspended through April.

The agency said the postponements involve routine surveillance inspections of outfits that make FDA-regulated products. “For cause” inspections — ones in which the FDA is investigating a specific problem, for example — will be evaluated on a case-by-case basis.

The agency already had suspended most inspections in China.

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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