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483
•Insmed Incorporated•April 3, 2025

Insmed Incorporated – FDA 483, Apr 3, 2025

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)
View Company Profile

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

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