FDA 483 - Bristol-Myers Squibb Company - July 18, 2025

An FDA inspection of Celgene Corporation in Summit, NJ, revealed significant deficiencies in the manufacturing of sterile drug products, Breyanzi and Abecma. Observations included failures in aseptic processing procedures, inadequate environmental monitoring, and insufficient investigation of discrepancies. The facility also exhibited issues with building maintenance and equipment qualification, indicating a lack of control over critical manufacturing processes.