US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists
Executive Summary
With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.
You may also be interested in...
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.
Pandemic Will Limit Role Of US FDA Inspections In Driving FY 2021 Drug GMP Sanctions
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.
The Quality Lowdown: COVID-19's Pressures On Drug Quality
Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.