Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-08.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jul 2024 – 8 Jul 2024 | Biologics | 483 | View 483 → |
| 25 Aug 2021 – 27 Aug 2021 | Biologics | 483 | View 483 → |
| 28 Feb 2018 – 5 Mar 2018 | Biologics | 483 | View 483 → |
| 3 Feb 2016 | Biologics | Clean | |
| 25 Jun 2014 | Biologics | Clean | |
| 26 Jun 2012 | Not recorded | Clean | |
| 16 Mar 2010 | Not recorded | Clean | |
| 21 Aug 2008 | Not recorded | 483 | On file |
| 21 Jul 2003 | Not recorded | Clean | |
| 11 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jul 2024
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by La-Tasha M Gunter
8 Jul 2024
21 CFR 606.151(e)
Procedures to maintain records of emergency transfusions
Cited by La-Tasha M Gunter
27 Aug 2021
21 CFR 606.140(b)
Provisions to monitor lab test procedures & instruments
Cited by Charles D Boison
5 Mar 2018
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by La-Tasha M Gunter
Investigators
FDA investigators tied to this site in the record.
La-Tasha M Gunter2 insp.
Charles D Boison1 insp.
Laurissa S Flowers1 insp.
Sandra Sejdinovic1 insp.
Thomas W Nojek1 insp.
Tania E Vizcaino1 insp.
Ana P Barido1 insp.
Marilyn M White1 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 606.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.140(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.151(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(a)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Department of Veterans Affairs Medical Center's 4 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