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US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says

 
• By Joanne S. Eglovitch

Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.

Facility inspection
GAO Tells FDA Not To Compromise High-Risk Facility Inspections Due To COVID-19 Backlog • Source: Shutterstock

The US Food and Drug Administration needs to make sure a backlog of overdue surveillance inspections that has been growing due to COVID-19 travel restrictions does not compromise its ability to conduct “high-risk” inspections going forward, a Government Accountability Office official says.

The agency also should more fully explore the use of alternatives to the on-site inspections the pandemic prevents it from conducting, said Mary Denigan-Macauley, director of GAO’s health care office,...

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