Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
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 |
|---|---|---|---|
| 26 Mar 2026 | Biologics | Clean | |
| 30 Apr 2019 – 1 May 2019 | Biologics | Clean | |
| 13 Dec 2016 – 15 Dec 2016 | Biologics | Clean | |
| 18 Nov 2014 | Biologics | Clean | |
| 18 Jun 2013 – 24 Jun 2013 | Biologics | 483 | On file |
| 30 Jan 2012 | Not recorded | 483 | View 483 → |
| 30 Oct 2009 | Not recorded | 483 | View 483 → |
| 3 Jun 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Oct 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Carmen Y Fisher
Investigators
FDA investigators tied to this site in the record.
Carmen Y Fisher3 insp.
William F Lagud2 insp.
Eric T Huebler1 insp.
Cody D Rickman1 insp.
Nicole J Conklin1 insp.
Farhana Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(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