Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-12-11.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Dec 2024 | Biologics | Clean | |
| 24 Sep 2019 | Biologics | Clean | |
| 21 Mar 2017 | Biologics | Clean | |
| 31 Mar 2015 – 8 Apr 2015 | Biologics | 483 | View 483 → |
| 25 Jun 2013 – 27 Jun 2013 | Biologics | Clean | |
| 15 Mar 2011 | Not recorded | Clean | |
| 25 Mar 2009 | Not recorded | Clean | |
| 27 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2015
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.
Victoria V Bot1 insp.
Shavon L Square1 insp.
Amy A Johnson1 insp.
Margaret Torres-Vazquez1 insp.
Amy C Amaro1 insp.
La-Tasha M Gunter1 insp.
Patricia A Morrow1 insp.
Tania E Vizcaino1 insp.
Ana P Barido1 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 |
Full site report
Get the verbatim findings behind Department of the Air Force, 11th Medical Group's 1 Form 483
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