FDA 483 - Celgene Corporation - August 04, 2015

An FDA inspection of Celgene Corporation in Berkeley Heights, NJ, revealed significant deficiencies in adverse drug experience reporting. The firm failed to submit numerous serious and unexpected adverse drug experience reports within the required 15 calendar days. This included over 1400 late reports for products like Revlimid, Abraxane, Pomalyst, and Otezla between January 2014 and July 2015.