FDA 483 - Bristol-Myers Squibb Company - March 19, 2010

Celgene Corporation, a corporate headquarters and control testing laboratory in Summit, NJ, was cited for significant quality control and production procedure deficiencies. Observations included inadequate visual inspection criteria for Azacitidine for Injection, leading to potential contamination, and a systemic failure to timely investigate critical deviations. Additionally, the firm used unvalidated API in commercial products and did not complete annual product reviews on time.