FDA-Inspected Site

University Of Michigan - IRBMED

7 FDA inspections are on record for University Of Michigan - IRBMED in Ann Arbor, United States.

483· Form 483 issued

Ann Arbor, United States · Last updated July 10, 2026

Overview

  • 7 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-20.

At a glance

Inspections

7

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 May 2026 – 20 May 2026Medical Devices & Rad Health483View 483 →
29 Aug 2022 – 2 Sep 2022Medical Devices & Rad Health483View 483 →
10 Jul 2018 – 27 Jul 2018Human Drugs483View 483 →
3 Jun 2014 – 17 Jun 2014Medical Devices & Rad Health483On file
12 Nov 2009Not recorded483View 483 →
16 Nov 2005Not recordedClean
6 Nov 2001Not recordedClean

Observations on record

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

20 May 2026
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Corrine M Carter, Dina A Tallman

20 May 2026
21 CFR 56.108(b)(1)

Prompt reporting of unanticipated problems

Cited by Corrine M Carter, Dina A Tallman

20 May 2026
21 CFR 56.110(c)

Method to keep members advised

Cited by Corrine M Carter, Dina A Tallman

2 Sep 2022
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Corrine M Carter, Jennifer A Kemp, Dina A Tallman

2 Sep 2022
21 CFR 56.110(c)

Method to keep members advised

Cited by Corrine M Carter, Jennifer A Kemp, Dina A Tallman

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 56.108(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 56.108(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 56.110(c)Cited across public-safe Form 483 observations3x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations3x
21 CFR 56.113Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind University Of Michigan - IRBMED's 5 Form 483s

Source PDFs, 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