FDA 483 - Bristol-Myers Squibb Company - January 25, 2017

An FDA inspection of Celgene Corporation's headquarters in Summit, NJ, revealed significant deficiencies in adverse drug experience reporting. The firm failed to report numerous serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. This included approximately 724 initial and follow-up reports submitted late between August 2015 and December 2016, with some delays extending over several years.