Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-13.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2026 | Biologics | Clean | |
| 23 Apr 2024 – 24 Apr 2024 | Biologics | 483 | On file |
| 24 Jun 2019 – 26 Jun 2019 | Biologics | 483 | View 483 → |
| 13 Apr 2017 | Biologics | Clean | |
| 5 Feb 2015 | Biologics | Clean | |
| 14 Dec 2012 | Not recorded | Clean | |
| 4 Jan 2011 | Not recorded | Clean | |
| 7 Nov 2008 | 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.
Carl A Huffman2 insp.
John A Iwen1 insp.
Ismael Olvera-Iv1 insp.
Irina Gaberman1 insp.
Leeterry Moore1 insp.
Jeanne J Thai1 insp.
Jeanne J Chiu1 insp.
Randy D Baxter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
Full site report
Get the verbatim findings behind this site's 2 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