Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-20.
At a glance
Inspections
10
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 20 Mar 2025 | Biologics | 483 | View 483 → |
| 24 May 2022 – 25 May 2022 | Biologics | Clean | |
| 5 Sep 2017 – 12 Sep 2017 | Biologics | 483 | View 483 → |
| 16 Mar 2015 – 18 Mar 2015 | Biologics | Clean | |
| 9 Jan 2013 | Not recorded | 483 | View 483 → |
| 14 Mar 2011 | Not recorded | 483 | On file |
| 18 Jun 2009 | Not recorded | Clean | |
| 14 Feb 2005 | Not recorded | Clean | |
| 21 Jan 2003 | Not recorded | Clean | |
| 5 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Conor J Mccarron1 insp.
Roger D Gawne1 insp.
Seyyida Saterfield1 insp.
Sherri J Jackson1 insp.
Mary E Wilkerson-Brinsko1 insp.
Jennifer H Rhyu1 insp.
Aneel K Sandhu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 Form 483s
Source PDFs, 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