FDA 483 - Bristol-Myers Squibb Company - July 30, 2012

An FDA inspection of Celgene Corporation's Summit, NJ facility revealed two significant issues. The firm failed to thoroughly review unexplained discrepancies, specifically concerning an off-white appearance defect in Azacitidine for Injection lots. Additionally, there was no written program for assessing drug product stability, and numerous Revlimid Capsule stability samples were not properly logged into stability chambers.