Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-21.
At a glance
Inspections
12
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jan 2025 – 21 Jan 2025 | Biologics | Clean | |
| 30 Nov 2021 – 1 Dec 2021 | Biologics | Clean | |
| 29 Aug 2017 – 31 Aug 2017 | Biologics | Clean | |
| 25 Jul 2016 – 15 Aug 2016 | Biologics | Clean | |
| 28 Jan 2015 – 11 Feb 2015 | Biologics | Clean | |
| 16 Apr 2013 – 23 Apr 2013 | Biologics | 483 | On file |
| 30 Mar 2011 | Not recorded | Clean | |
| 21 Aug 2009 | Not recorded | 483 | View 483 → |
| 7 Jul 2006 | Not recorded | Clean | |
| 23 Aug 2004 | Not recorded | Clean | |
| 7 Aug 2002 | Not recorded | Clean | |
| 8 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Aug 2009
21 CFR 606.151(e)
Procedures to maintain records of emergency transfusions
Cited by Karen M Cooper
Investigators
FDA investigators tied to this site in the record.
Brandon L Mariner3 insp.
Margaret Torres-Vazquez2 insp.
La-Tasha M Gunter1 insp.
Laurie P Norwood1 insp.
Laurissa S Flowers1 insp.
Linda S Mattingly1 insp.
Marion W Nadeau1 insp.
Karen M Cooper1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e) | 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)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 Form 483s
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