Pink Sheet

Warning Letters Special Report: Pandemic Drove Focused Inspections, Alternative Approaches

04 Apr 2023

In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.

Warning Letters Special Report — How the FDA found so many problems with so few inspections • Source: Shutterstock

Two factors enabled the US Food and Drug Administration to continue pressing the pharmaceutical industry on quality with warning letters in 2021 and 2022 even after the COVID-19 pandemic largely grounded its inspectorate, according to agency data analyzed by the Pink Sheet.

One: The agency became more selective with the drug good manufacturing practice inspections it was able to conduct.