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US FDA Facility Records Review Evolved Into More Formal Process As Pandemic Continued

 
• By Derrick Gingery

With more experience, the US FDA was able to standardize record review requests and timing.

Files in an office
The US FDA improved communication with sponsors before and after records reviews as it became more comfortable with the process. • Source: Alamy

The US Food and Drug Administration’s records request process that substituted for many facility inspections during the coronavirus pandemic began as a somewhat haphazard practice before becoming a more formal system.

Mission-critical inspections continue to be conducted in person when needed. Facilities can be eligible for a records review in lieu of a pre-approval inspection (PAI) if an evaluation of information...

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