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

Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.

The Quality Lowdown

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 Quality Lowdown examines some of those findings that are not especially uplifting.

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