FDA 483 - Celgene Corporation - August 25, 2011

An FDA inspection of Celgene Corporation in Berkeley Heights, NJ, revealed two significant issues. The firm failed to include status reports for all postmarketing clinical studies in their NDA Annual Reports for products like Revlimid and Istodax. Additionally, Celgene Corporation did not report all serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days, with a significant number of reports being submitted more than 100 days late.