Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-10.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 10 Feb 2026 | Biologics | 483 | View 483 → |
| 30 Nov 2022 – 1 Dec 2022 | Biologics | Clean | |
| 6 Jun 2018 | Biologics | Clean | |
| 17 Mar 2016 | Biologics | Clean | |
| 13 May 2014 | Biologics | Clean | |
| 13 Sep 2012 | Not recorded | Clean | |
| 17 Nov 2010 | Not recorded | Clean | |
| 9 Dec 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Margaret E Digennaro2 insp.
Kimberly A Dux2 insp.
Michele Gottshall1 insp.
Erika M Wilkerson1 insp.
Timothy J Schmidt1 insp.
Ann-Marie Karnick1 insp.
Michele M Falchek1 insp.
Dawn D Aiello1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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