FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Grassley Calls for Unannounced Inspections of Foreign Drugmakers

Aug. 13, 2019
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Sen. Chuck Grassley (R-Iowa) has urged the FDA to begin inspections of all overseas drug manufacturing facilities without prior notice.

In a letter to HHS Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, Grassley slammed the agency’s foreign drug inspection program, noting that most API production happens outside the U.S.

The FDA conducts unannounced visits at U.S. facilities, but generally doesn’t do that  abroad despite their proven success, he said. The agency only inspected one in five registered human drugmaking facilities overseas last year, although 80 percent of APIs are produced abroad, mostly in China and India, he noted.

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