Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-10.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jul 2026 – 10 Jul 2026 | Biologics | Clean | |
| 5 Feb 2024 – 13 Feb 2024 | Biologics | Clean | |
| 19 Apr 2018 – 27 Apr 2018 | Biologics | 483 | On file |
| 10 Jun 2016 – 15 Jun 2016 | Biologics | Clean | |
| 25 Aug 2014 – 29 Aug 2014 | Biologics | 483 | On file |
| 4 Nov 2011 | Not recorded | 483 | View 483 → |
| 19 Aug 2010 | Not recorded | Clean | |
| 4 Dec 2009 | Not recorded | 483 | On file |
| 26 Feb 2008 | Not recorded | 483 | On file |
| 16 Feb 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2011
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Helen B Ricalde
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry3 insp.
Carl E Lovrich2 insp.
Helen B Ricalde2 insp.
Richard T Riggie1 insp.
Simone E Pitts1 insp.
Amanda B Athey1 insp.
Brandon L Mariner1 insp.
Joyce A Rockwell1 insp.
Oumou Barry1 insp.
James W Leonette1 insp.
Prabhu P Raju1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 601.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 601.12(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 5 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