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Remote Methods Drove Most US FDA Enforcement Actions In FY 2021

 
• By Shannon Brown

Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.

The FDA is making increased use of remote records requests and product sampling • Source: Alamy

As remote records reviews conducted during the pandemic begin to account for a growing share of warning letters, experts advise industry to prepare for remote US Food and Drug Administration oversight to continue even after routine site inspections resume and the pandemic recedes.

The FDA, which historically relied solely on site inspections as a basis for drug adulteration warning letters, has only based 28% of warning letters issued in the first 11 months of fiscal year 2021 on site

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