Overview
- 11 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-12.
At a glance
Inspections
11
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2026 – 12 Jun 2026 | Biologics | 483 | View 483 → |
| 10 Sep 2024 – 12 Sep 2024 | Biologics | 483 | View 483 → |
| 9 May 2022 – 13 May 2022 | Biologics | Clean | |
| 22 Apr 2019 – 26 Apr 2019 | Biologics | Clean | |
| 20 Jun 2017 – 23 Jun 2017 | Biologics | Clean | |
| 14 Sep 2015 – 16 Sep 2015 | Biologics | Clean | |
| 15 Mar 2012 | Not recorded | 483 | View 483 → |
| 14 Jul 2010 | Not recorded | Clean | |
| 6 Jun 2008 | Not recorded | Clean | |
| 16 Jan 2004 | Not recorded | Clean | |
| 17 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Sep 2024
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by La-Tasha M Gunter
12 Sep 2024
21 CFR 606.151(e)
Procedures to maintain records of emergency transfusions
Cited by La-Tasha M Gunter
15 Mar 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Carrie L Doupnik
Investigators
FDA investigators tied to this site in the record.
Charles D Boison4 insp.
La-Tasha M Gunter2 insp.
Richard J Bashay1 insp.
Brandon L Mariner1 insp.
Carrie L Doupnik1 insp.
Melissa D Kalik1 insp.
Gerald Mierle1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.151(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind University Of Virginia Health System'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