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Form 483

Brigham And Women's Hospital Form 483, 2019-09-26

FDA issued a Form 483 to Brigham And Women's Hospital on 2019-09-26 with 6 public-safe observations.

483· Form 483 issuedBiologics6 observations

Brigham And Women's Hospital · Boston, United States · Issued September 26, 2019

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

26 Sep 2019
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Alice C Silva

26 Sep 2019
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Alice C Silva

26 Sep 2019
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Alice C Silva

26 Sep 2019
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Alice C Silva

26 Sep 2019
21 CFR 1271.85(a)

Infection with communicable disease agents

Cited by Alice C Silva

Inspected site

BABrigham And Women's HospitalBoston, United States

Inspection team

ACAlice C Silva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations2x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 1271.85(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF, 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