Insmed IncorporatedApril 3, 2025

FDA 483 - Insmed Incorporated - April 03, 2025

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Record Details

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.

Company: Insmed Incorporated
Inspection Date: April 3, 2025
Product Type: Drugs
Office: New Jersey District Office
Person: Michael Serrano (investigator)

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ID · d48d0d07-21b7-4991-863b-e1354589f4ec