Atlas

Form 483

Wayne State University IRB Form 483, 2012-01-26

FDA issued a Form 483 to Wayne State University IRB on 2012-01-26 with 1 public-safe observation.

483· Form 483 issued1 observation

Wayne State University IRB · Detroit, United States · Issued January 26, 2012

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

26 Jan 2012
21 CFR 56.110(b)(2)

Minor changes

Cited by Neali H Lucas, L'Oreal F Walker, Nancy A Bellamy

Inspected site

WSWayne State University IRBDetroit, United States

Inspection team

NHNeali H Lucas
LFL'Oreal F Walker
NANancy A Bellamy

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.110(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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