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Form 483

Children's National Medical Center IRB Form 483, 2025-05-20

FDA issued a Form 483 to Children's National Medical Center IRB on 2025-05-20 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Children's National Medical Center IRB · Washington, United States · Issued May 20, 2025

Overview

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

Inspectional observations

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

20 May 2025
21 CFR 56.109(b)

Information given to subjects

Cited by Brittany L Carpenter

Inspected site

CNChildren's National Medical Center IRBWashington, United States

Inspection team

BLBrittany L Carpenter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.109(b)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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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