Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-08.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Aug 2025 – 8 Aug 2025 | Medical Devices & Rad Health | Clean | |
| 6 Feb 2020 – 14 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Apr 2016 – 3 May 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Dec 2013 – 12 Dec 2013 | Human Drugs | 483 | View 483 → |
| 29 Sep 2011 | Not recorded | Clean | |
| 2 Jun 2010 | Not recorded | Clean | |
| 17 Sep 2009 | Not recorded | Clean | |
| 10 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Corrine M Carter2 insp.
Myra K Casey2 insp.
Andrea D Swingle2 insp.
Chelsea W Lamm1 insp.
Victoria R Flournoy1 insp.
Dawn C Olenjack1 insp.
Kimberly A Dux1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.110(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Indiana University IRB's 3 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