Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-02.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2025 – 2 Jun 2025 | Biologics | Clean | |
| 13 Feb 2019 – 14 Feb 2019 | Biologics | Clean | |
| 13 Mar 2018 – 20 Mar 2018 | Biologics | 483 | View 483 → |
| 6 Jan 2016 – 7 Jan 2016 | Biologics | Clean | |
| 23 Jul 2013 – 25 Jul 2013 | Biologics | 483 | On file |
| 22 Jun 2011 | Not recorded | Clean | |
| 2 Mar 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz2 insp.
Erma Zaimova2 insp.
Amy S Graf1 insp.
Neali H Lucas1 insp.
Sherri J Jackson1 insp.
Catherine V Quinlan1 insp.
Adam J Wilson1 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 | 4x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(b) | 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