Preparing For The Return Of US FDA Inspections

06 Feb 2021

FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.

Pharmaceutical Industry Worker at Work — how will quality stay while the fda is away? • Source: Shutterstock

As waves of fear gripped the world, travel restrictions due to the SARS-CoV-2 pandemic last year swiftly brought profound changes to the US Food and Drug Administration’s enforcement program that are continuing to unfold today and will reverberate in the years ahead.

Compared to the year before, FDA data shows that agency inspections of drug manufacturing facilities in fiscal year 2020 fell...