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Pandemic Will Continue Limiting US FDA Inspections In Driving FY 2021 Drug GMP Warnings

 
• By Bowman Cox

FDA historically has based 100% of drug adulteration warning letters on inspections but COVID-19-related travel restrictions began changing that in FY 2020, when 2% of drug GMP warning letters were based on testing import samples. The change became even more pronounced in the first two months of FY 2021, with 59% of actions related to sample testing and 41% to inspections.

Many if not most of the drug adulteration regulatory actions by the US Food and Drug Administration in fiscal year 2021 will be based on alternatives to agency inspections that are precluded by coronavirus-related travel restrictions, according to Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

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