Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-13.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 | Biologics | Clean | |
| 10 Jul 2023 – 12 Jul 2023 | Biologics | Clean | |
| 16 Jul 2018 – 17 Jul 2018 | Biologics | Clean | |
| 22 Jun 2016 – 24 Jun 2016 | Biologics | Clean | |
| 30 Apr 2014 – 5 May 2014 | Biologics | Clean | |
| 17 May 2012 | Not recorded | 483 | On file |
| 27 Aug 2010 | Not recorded | 483 | View 483 → |
| 31 Jul 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Aug 2010
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Barbara A Rusin
27 Aug 2010
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Barbara A Rusin
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz3 insp.
Neali H Lucas2 insp.
Uruaku A Obasi1 insp.
Erma Zaimova1 insp.
Angela J Alexander1 insp.
L'Oreal F Walker1 insp.
Barbara A Rusin1 insp.
Catherine V Quinlan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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