Atlas

Form 483

Children's National Medical Center IRB Form 483, 2019-06-06

FDA issued a Form 483 to Children's National Medical Center IRB on 2019-06-06 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Children's National Medical Center IRB · Washington, United States · Issued June 6, 2019

Overview

  • 3 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.

6 Jun 2019
21 CFR 56.108(c)

Members present for review

Cited by Kathryn Suttling

6 Jun 2019
21 CFR 56.108(b)(2)

Prompt reporting of noncompliance

Cited by Kathryn Suttling

6 Jun 2019
21 CFR 56.115(a)(5)

List of members

Cited by Kathryn Suttling

Inspected site

CNChildren's National Medical Center IRBWashington, United States

Inspection team

KSKathryn Suttling

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.108(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.108(c)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(5)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 3 observations

The source PDF and every observation in full, 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