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

Source: https://www.keypedia.com/records/483/insmed-inc/cac90158-c61e-4f6c-8640-72f46b7f56f8

> FDA 483 for Insmed, Inc. on August 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Insmed, Inc.
- Inspection Date: 2021-08-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)

Company: https://www.keypedia.com/companies/insmed-inc/50b576e9-e125-4d86-982e-54ac595a6b70

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248