FDA 483 - Insmed, Inc. - August 03, 2021

An FDA inspection of Insmed, Inc. in Bridgewater, NJ, revealed a significant deficiency in their post-marketing surveillance system. The firm failed to develop written procedures for monitoring adverse drug experiences, which resulted in a serious, unexpected adverse event related to their drug Iplex (NDA 021884) not being reported to the FDA. This indicates a lapse in pharmacovigilance practices.