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

Executive Summary

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.

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