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Form 483

Brigham and Women's Hospital, Inc., The Form 483, 2026-06-22

FDA issued a Form 483 to Brigham and Women's Hospital, Inc., The on 2026-06-22 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Brigham and Women's Hospital, Inc., The · Boston, United States · Issued June 22, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

22 Jun 2026
21 CFR 212.30(a)

Orderly handling, prevention of mix-ups, prevention of contamination

Cited by Sean R Marcsisin, Ifechimere I Okafor

Inspected site

BABrigham and Women's Hospital, Inc., TheBoston, United States

Inspection team

SRSean R Marcsisin
IIIfechimere I Okafor

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.30(a)Cited across public-safe Form 483 observations1x

Full 483 report

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The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere