Warning Letters Special Report: Where Investigations By Prescription Drug Product Firms Fell Short

Warning letters examined in part five of our in-depth report showed how prescription drug firms got into trouble with the US FDA in 2022 by conducting investigations that were too narrow and that failed to trigger appropriate corrective actions. Several firms failed in their sterile injectables contamination investigations. Other inquiries failed to establish proper control of tablet and capsule manufacturing.

2022 Warning Letters Special Report
a closer look at what went wrong • Source: Shutterstock

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