Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-06-02.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2026 – 2 Jun 2026 | Biologics | Clean | |
| 23 Jan 2023 | Biologics | Clean | |
| 18 Sep 2017 | Biologics | Clean | |
| 15 Sep 2015 – 16 Sep 2015 | Biologics | Clean | |
| 12 Dec 2012 | Not recorded | Clean | |
| 9 May 2011 | Not recorded | 483 | View 483 → |
| 19 May 2010 | Not recorded | Clean | |
| 9 Aug 2007 | Not recorded | Clean | |
| 21 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Timothy P Lafave
Investigators
FDA investigators tied to this site in the record.
Timothy P Lafave2 insp.
Melsomar R Ramos1 insp.
Celeta S Coves1 insp.
Laurissa S Flowers1 insp.
Lauren E Swantko1 insp.
Robert S Sweeton1 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 |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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