Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-21.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2026 | Biologics | Clean | |
| 9 Dec 2021 | Biologics | Clean | |
| 27 Nov 2018 – 4 Dec 2018 | Biologics | Clean | |
| 2 Mar 2017 – 9 Mar 2017 | Biologics | 483 | View 483 → |
| 19 Feb 2015 – 26 Feb 2015 | Biologics | Clean | |
| 5 Mar 2013 – 8 Mar 2013 | Biologics | 483 | On file |
| 28 Oct 2011 | Not recorded | 483 | View 483 → |
| 5 Aug 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Mar 2017
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Elizabeth B Griffin
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 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(21) | 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 4 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