FDA 483 - Barr Laboratories Inc. - November 04, 2022

An FDA inspection of Barr Laboratories, Inc. in Forest, VA, identified a critical quality control deficiency regarding their discrepancy review process. The firm failed to thoroughly investigate the isolation of Bacillus cereus in a batch of oral tablets, subsequently releasing some of the affected product for commercial distribution without identifying a root cause. This indicates a serious lapse in their quality unit's oversight and potential product contamination risk.