FDA 483 - Allergan Sales, LLC - November 07, 2025

Allergan Sales, LLC (BLI) in Irvine, CA, was cited for significant deficiencies in its drug substance manufacturing processes, particularly concerning contamination control and environmental monitoring. The inspection revealed inadequate process design, insufficient microbial control strategies, and flawed risk assessments, indicating a lack of assurance in maintaining drug substance quality and preventing contamination.