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.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 20 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Aug 2022 – 2 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jul 2018 – 27 Jul 2018 | Human Drugs | 483 | View 483 → |
| 3 Jun 2014 – 17 Jun 2014 | Medical Devices & Rad Health | 483 | On file |
| 12 Nov 2009 | Not recorded | 483 | View 483 → |
| 16 Nov 2005 | Not recorded | Clean | |
| 6 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Initial and continuing reviews
Cited by Corrine M Carter, Dina A Tallman
Prompt reporting of unanticipated problems
Cited by Corrine M Carter, Dina A Tallman
Initial and continuing reviews
Cited by Corrine M Carter, Jennifer A Kemp, Dina A Tallman
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.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 56.108(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 56.108(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 56.110(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 56.113 | Cited across public-safe Form 483 observations | 2x |
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