The Quality Lowdown: No Longer Stoppered By Pandemic, US FDA Finds Serious Problems

Adverse findings from some early- to mid-2022 US Food and Drug Administration site inspections have been trickling out, providing an inkling of how drug manufacturing quality may have declined during the COVID-19 pandemic inspection hiatus in two areas of great interest to the agency – sterile manufacturing of injectable drugs and manufacturing of active pharmaceutical ingredients.

This edition of the