US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists
With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.
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US FDA’s Donald Ashley recaps past year’s precedent-setting responses to COVID-19 pandemic in interview, while outlining return to pre-COVID priorities and traditional inspection-based oversight.
US FDA’s Donald Ashley recaps the past year’s precedent-setting responses to the COVID-19 pandemic in Pink Sheet interview, while outlining a return to pre-COVID priorities and traditional inspection-based oversight.
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.