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Inspection-Challenged FDA Defies Odds By Issuing Most Quality-Related Warning Letters Since 2017

 
• By Shawn M. Schmitt

US FDA data shared with Medtech Insight show that the number of quality-related warning letters sent to device manufacturers in calendar year 2021 ticked up 33% from 2020. Last year’s enforcement missives were also the most handed out by the agency in four years.

Vintage inscription made by old typewriter, warning

As the US Food and Drug Administration grappled with conducting on-site facility inspections in calendar year 2021, agency data show that the number of quality-related warning letters sent to device makers ticked up 33% from the prior year.

The FDA told Medtech Insight it mailed 28 quality-related enforcement missives to device makers last year – seven more than it sent in 2020, when on-site in-person inspections all but...

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