Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-03.
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 |
|---|---|---|---|
| 2 Apr 2025 – 3 Apr 2025 | Biologics | Clean | |
| 25 Sep 2023 | Biologics | Clean | |
| 18 Dec 2019 – 19 Dec 2019 | Biologics | Clean | |
| 10 Jan 2018 – 24 Jan 2018 | Biologics | 483 | View 483 → |
| 23 Feb 2016 – 26 Feb 2016 | Biologics | 483 | View 483 → |
| 28 Oct 2013 | Biologics | Clean | |
| 20 Jun 2012 | Not recorded | Clean | |
| 26 Jan 2010 | 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.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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