Atlas

Form 483

Aultman Health Foundation HRRB Form 483, 2017-06-28

FDA issued a Form 483 to Aultman Health Foundation HRRB on 2017-06-28 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Aultman Health Foundation HRRB · Canton, United States · Issued June 28, 2017

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.

28 Jun 2017
21 CFR 56.109(e)

IRB approvals/disapprovals - general

Cited by Geoffrey K Kilili

28 Jun 2017
21 CFR 56.110(b)

Research not eligible for expedited review

Cited by Geoffrey K Kilili

28 Jun 2017
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Geoffrey K Kilili

Inspected site

AHAultman Health Foundation HRRBCanton, United States

Inspection team

GKGeoffrey K Kilili

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.109(e)Cited across public-safe Form 483 observations1x
21 CFR 56.110(b)Cited 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 3 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