FDA 483 - Bristol-Myers Squibb Company - June 16, 2023

Celgene Corporation in Summit, NJ, a licensed biological drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations include a lack of appropriate stability data for drug product expiration dating and inadequate validated procedures for visual inspection of Abecma. Furthermore, the firm's aseptic processing areas showed critical failures in environmental and personnel monitoring, alongside facility design issues that could compromise contamination control.