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Could Virtual Tools Help US FDA Eliminate Inspection Backlog?

 
• By Derrick Gingery

A former CDER compliance office director suggested the agency initiate virtual visits at low-risk facilities to help catch up on manufacturing facility surveillance inspections.

document review
Three to five RRAs, which involve document reviews, could be conducted in the same time as one inspection, Donald Ashley said. • Source: Shutterstock

Increasing virtual inspections may help the US Food and Drug Administration reduce its surveillance inspection backlog, but public health needs could complicate such a plan.

During the height of the COVID-19 pandemic, most international travel was restricted or not feasible, meaning many routine inspections of drug manufacturing facilities were postponed. The result was a substantial...

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