483
Insmed, Inc.FDA 483 - Insmed, Inc. - August 03, 2021
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Record Details
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.
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ID · cac90158-c61e-4f6c-8640-72f46b7f56f8