Atlas

FDA-Inspected Site

Wayne State University IRB

6 FDA inspections are on record for Wayne State University IRB in Detroit, United States.

Clean· No action indicated

Detroit, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-11-01.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Oct 2019 – 1 Nov 2019Medical Devices & Rad HealthClean
8 May 2017 – 12 May 2017Medical Devices & Rad HealthClean
26 Jan 2012Not recorded483View 483 →
2 Feb 2010Not recordedWLView 483 →
19 Aug 2005Not recordedClean
19 Apr 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

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

Minor changes

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

2 Feb 2010
21 CFR 56.107(d)

One non-affiliate member

Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen

2 Feb 2010
21 CFR 56.107(f)

Invited individual allowed to vote with IRB

Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen

2 Feb 2010
21 CFR 56.108(c)

Members present for review

Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen

2 Feb 2010
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen

Investigators

FDA investigators tied to this site in the record.

Neali H Lucas2 insp.
Nancy A Bellamy2 insp.
Andrace Deyampert1 insp.
Corrine M Carter1 insp.
L'Oreal F Walker1 insp.
Sherri J Jackson1 insp.
Laureen F Kononen1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 56.107(d)Cited across public-safe Form 483 observations1x
21 CFR 56.107(f)Cited across public-safe Form 483 observations1x
21 CFR 56.108(c)Cited across public-safe Form 483 observations1x
21 CFR 56.110(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(5)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Wayne State University IRB's 2 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat