# FDA 483 - Insmed Incorporated - April 03, 2025

Source: https://www.keypedia.com/records/483/insmed-incorporated/d48d0d07-21b7-4991-863b-e1354589f4ec

> FDA 483 for Insmed Incorporated on April 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Insmed Incorporated
- Inspection Date: 2025-04-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Insmed Incorporated, a corporate headquarters in Bridgewater, NJ, was inspected by the FDA from March 24 to April 3, 2025. The inspection revealed a significant failure to adhere to study protocols, specifically regarding the reporting of primary efficacy endpoints. This indicates a serious lapse in clinical trial conduct and data integrity.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/insmed-incorporated/2b1442ae-b800-4f95-90a5-f0891d7adc79

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