Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-02.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jun 2026 – 2 Jul 2026 | Biologics | Clean | |
| 15 Nov 2023 – 28 Nov 2023 | Biologics | 483 | View 483 → |
| 9 Apr 2019 – 10 Apr 2019 | Biologics | Clean | |
| 5 Apr 2017 – 6 Apr 2017 | Biologics | Clean | |
| 19 Nov 2014 – 2 Dec 2014 | Biologics | 483 | View 483 → |
| 29 Jan 2013 | Not recorded | Clean | |
| 15 Feb 2011 | Not recorded | Clean | |
| 9 Apr 2009 | Not recorded | 483 | View 483 → |
| 12 Feb 2007 | Not recorded | Clean | |
| 24 Sep 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Nov 2023
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Irina Gaberman
Investigators
FDA investigators tied to this site in the record.
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 | 2x |
| 21 CFR 606.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 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 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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