FDA 483 - Barr Laboratories Inc. - November 04, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 344e391b-330e-4570-b63c-f374431099ff