Atlas

Form 483

Nationwide Children's Hospital IRB Form 483, 2013-01-25

FDA issued a Form 483 to Nationwide Children's Hospital IRB on 2013-01-25 with 2 public-safe observations.

483· Form 483 issued2 observations

Nationwide Children's Hospital IRB · Columbus, United States · Issued January 25, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

25 Jan 2013
21 CFR 50.52

Factors required for approval

Cited by Jennifer L Jager

25 Jan 2013
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Jennifer L Jager

Inspected site

NCNationwide Children's Hospital IRBColumbus, United States

Inspection team

JLJennifer L Jager

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.52Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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