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US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists

 
• By Bowman Cox

With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.

man in a white robe and a mask with a tablet in his hands is near can in the shop
industry waiting for us fda reinspections during pandemic • Source: Shutterstock

Drug manufacturers that have remediated serious quality problems identified during US Food and Drug Administration inspections will have to keep waiting until after the coronavirus pandemic subsides for the follow-up site inspections that could green-light resumption of site-related application reviews – at least for the time being.

With the FDA’s inspectorate grounded since mid-March for all but the agency’s most pressing “mission-critical” inspections, the pharmaceutical industry has grown increasingly frustrated by delays of these follow-up inspections, which are among its highest priorities

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