FDA-Inspected Site

Insmed Incorporated

4 FDA inspections are on record for Insmed Incorporated in Bridgewater, United States.

483· Form 483 issued

Bridgewater, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-03.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Mar 2025 – 3 Apr 2025Human Drugs483View 483 →
26 Jul 2021 – 3 Aug 2021Human Drugs483View 483 →
21 Jan 2009Not recordedClean
27 Oct 2006Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

3 Apr 2025
21 CFR 312.50

General responsibilities of sponsors

Cited by Michael Serrano

3 Aug 2021
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Nina Yang

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Insmed Incorporated's 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat