Atlas

Form 483

OhioHealth Institutional Review Board Form 483, 2015-11-12

FDA issued a Form 483 to OhioHealth Institutional Review Board on 2015-11-12 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

OhioHealth Institutional Review Board · Columbus, United States · Issued November 12, 2015

Overview

  • 2 public-safe observations are 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.

12 Nov 2015
21 CFR 50.25(a)(2)

Reasonably foreseeable risks or discomforts

Cited by Richard W Berning

12 Nov 2015
21 CFR 50.25(a)(2)

Reasonably foreseeable risks or discomfo

Cited by Richard W Berning

Inspected site

OIOhioHealth Institutional Review BoardColumbus, United States

Inspection team

RWRichard W Berning

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.25(a)(2)Cited across public-safe Form 483 observations2x

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