Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-11.
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 |
|---|---|---|---|
| 10 Jul 2025 – 11 Jul 2025 | Biologics | Clean | |
| 12 Apr 2023 – 14 Apr 2023 | Biologics | Clean | |
| 13 Jul 2018 – 16 Jul 2018 | Biologics | Clean | |
| 6 Sep 2016 – 8 Sep 2016 | Biologics | Clean | |
| 9 Dec 2014 – 12 Dec 2014 | Biologics | Clean | |
| 20 Feb 2013 – 25 Feb 2013 | Biologics | Clean | |
| 25 Jan 2011 | Not recorded | 483 | View 483 → |
| 15 Jul 2009 | Not recorded | Clean | |
| 17 Jan 2008 | Not recorded | 483 | On file |
| 21 Apr 2003 | Not recorded | Clean | |
| 11 Mar 2002 | Not recorded | Clean | |
| 10 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jan 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Barbara A Rusin
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz4 insp.
L'Oreal F Walker2 insp.
Barbara A Rusin2 insp.
Catherine V Quinlan2 insp.
Randy L Clarida1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | 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