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Pandemic Will Limit Role Of US FDA Inspections In Driving FY 2021 Drug GMP Sanctions

 
• By Bowman Cox

Look for alternative approaches like sample testing, remote records review and reliance on trusted host nation authorities to fill many inspection gaps – except for OAI re-inspections. Meanwhile, post-emergency planning begins.

Toolbox With Various Worktools On Wooden Surface
us fda will continue to rely on new enforcement tools as pandemic continues

Many if not most of the drug adulteration regulatory actions the US Food and Drug Administration takes in fiscal year 2021 will be based on alternatives to FDA inspections that are prevented 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.

“I anticipate that for the remainder of this fiscal year that a large percentage, and, who knows, perhaps the majority of our adulteration regulatory actions will continue to be based upon these alternative tools rather than FDA inspections,” Ashley on 15 December told

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