FDA 483 - Bristol-Myers Squibb Company - February 19, 2021

Celgene Corporation, a Bristol Myers Squibb Company, a CAR-T Cell Manufacturer in Summit, NJ, was cited for three observations during an FDA inspection. The observations primarily concern inadequate aseptic practices leading to potential microbial contamination, failures within the quality control unit regarding material storage and temperature monitoring, and a lack of written procedures for managing escalated deviations and product recalls. These issues indicate significant deficiencies in maintaining product quality and regulatory compliance.