The Food and Drug Administration inspects foreign and domestic drug manufacturers to ensure drug safety and effectiveness. More than 50% of manufacturers supplying the U.S. market are located overseas—many in India and China.
The pandemic postponed almost all foreign inspections for most of 2020. But the number of these inspections had generally been declining since FY 2016—which FDA attributes in part to fewer investigators.
We recommended that FDA, among other things, develop tailored strategies and time frames to recruit and retain investigators for its foreign inspection workforce, which could help address a backlog of inspections.
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This article originally appears at U.S. Government Accountability Office site. To read the full report, click here.