Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-22.
At a glance
Inspections
11
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2024 – 22 Nov 2024 | Biologics | Clean | |
| 7 Sep 2022 – 29 Sep 2022 | Biologics | 483 | View 483 → |
| 19 Mar 2018 – 21 Mar 2018 | Biologics | Clean | |
| 22 Feb 2016 – 26 Feb 2016 | Biologics | Clean | |
| 22 Apr 2014 – 28 Apr 2014 | Biologics | Clean | |
| 21 May 2012 | Not recorded | 483 | View 483 → |
| 30 Jun 2010 | Not recorded | Clean | |
| 23 Jul 2008 | Not recorded | Clean | |
| 8 Mar 2004 | Not recorded | Clean | |
| 17 Nov 2000 | Not recorded | Clean | |
| 18 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2022
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Yvonne C Wilkes
29 Sep 2022
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Yvonne C Wilkes
29 Sep 2022
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Yvonne C Wilkes
Investigators
FDA investigators tied to this site in the record.
Yvonne C Wilkes4 insp.
Gene D Arcy2 insp.
Melsomar R Ramos1 insp.
Laurissa S Flowers1 insp.
Ana Djurdjevic1 insp.
Trushani T Desai1 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 | 3x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(c) | 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