Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-13.
At a glance
Inspections
12
Form 483s
4
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Mar 2026 – 13 Mar 2026 | Biologics | Clean | |
| 27 Nov 2023 – 1 Dec 2023 | Human Drugs | 483 | View 483 → |
| 14 Sep 2021 – 24 Sep 2021 | Human Drugs | Clean | |
| 12 Oct 2016 – 26 Oct 2016 | Human Drugs | 483 | On file |
| 18 Nov 2013 – 20 Nov 2013 | Animal Drugs & Feeds | 483 | On file |
| 30 Jan 2013 | Not recorded | Clean | |
| 5 Oct 2010 | Not recorded | 483 | On file |
| 1 Mar 2007 | Not recorded | Clean | |
| 7 Jan 2005 | Not recorded | Clean | |
| 8 Dec 2003 | Not recorded | Clean | |
| 17 Aug 2000 | Not recorded | Clean | |
| 18 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Dec 2023
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.81(a)
SOPs: authorization and documentation of deviations
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.81(a)
SOPs: laboratory methods
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.81(a)
SOPs: authorization and documentation of deviations
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
Investigators
FDA investigators tied to this site in the record.
Yuanyuan Li2 insp.
Jeanne J Thai2 insp.
Marcia A Worley2 insp.
Colleen E Burke1 insp.
Erin M Mcdowell1 insp.
Scott B Laufenberg1 insp.
Jennifer C Adams1 insp.
Lequita M Mayhew1 insp.
Tara C Alcazar1 insp.
Kathleen S Tormey1 insp.
Margaret Torres-Vazquez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind IIT Research Institute's 4 Form 483s
Source PDFs 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