Atlas

Form 483

William Beaumont Hospital IRB Form 483, 2016-02-19

FDA issued a Form 483 to William Beaumont Hospital IRB on 2016-02-19 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

William Beaumont Hospital IRB · Royal Oak, United States · Issued February 19, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

19 Feb 2016
21 CFR 56.108(b)(2)

Prompt reporting of noncompliance

Cited by Erma Zaimova, Andrace Deyampert

19 Feb 2016
21 CFR 56.113

Reporting

Cited by Erma Zaimova, Andrace Deyampert

19 Feb 2016
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Erma Zaimova, Andrace Deyampert

Inspected site

WBWilliam Beaumont Hospital IRBRoyal Oak, United States

Inspection team

EZErma Zaimova
ADAndrace Deyampert

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 56.113Cited 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