Pandemic Will Continue Limiting US FDA Inspections In Driving FY 2021 Drug GMP Warnings
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.
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Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.
Yuyao YiJia Daily Chemical told FDA placed all drugs it manufactures on import alert in September because its methods and controls for manufacturing OTC sanitizers and other products do not appear to conform to current drug GMPs.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.