Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-23.
At a glance
Inspections
10
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2025 – 23 Jan 2025 | Biologics | Clean | |
| 29 Apr 2019 – 1 May 2019 | Biologics | Clean | |
| 20 Sep 2016 – 21 Sep 2016 | Biologics | Clean | |
| 24 Feb 2014 – 27 Feb 2014 | Biologics | Clean | |
| 24 Aug 2012 | Not recorded | Clean | |
| 9 Jun 2011 | Not recorded | 483 | View 483 → |
| 27 Aug 2009 | Not recorded | 483 | View 483 → |
| 10 Mar 2006 | Not recorded | Clean | |
| 1 Sep 2004 | Not recorded | Clean | |
| 21 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jun 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Timothy P Lafave
9 Jun 2011
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Timothy P Lafave
Investigators
FDA investigators tied to this site in the record.
Timothy P Lafave3 insp.
Dylan R Jock1 insp.
Yvonne C Wilkes1 insp.
Comyar Shoghi1 insp.
Lawrence H Howell1 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 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 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 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