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Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels

 
• By Shawn M. Schmitt

An FDA budget request released on 28 May estimates that domestic GMP inspections of US device makers will increase from a mere 75 in the current 2021 fiscal year to 1,400 in FY 2022. It also asks for an increase of $18.8m to pay for inspections of all commodities the agency oversees.

Vegetation makes a comeback.

A budget request for the US Food and Drug Administration released by the White House on 28 May predicts that domestic GMP inspections of device makers will increase by a whopping 1,767% in fiscal year 2022.

The FDA estimates it will conduct only 75 inspections in the current fiscal year, which ends on September 30. But...

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