Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-22.
At a glance
Inspections
11
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 22 Apr 2026 | Biologics | Clean | |
| 5 Oct 2023 – 13 Oct 2023 | Biologics | 483 | View 483 → |
| 26 Apr 2022 | Biologics | Clean | |
| 19 Jul 2018 – 26 Jul 2018 | Biologics | Clean | |
| 21 Sep 2016 – 22 Sep 2016 | Biologics | Clean | |
| 14 Jul 2014 – 15 Jul 2014 | Biologics | Clean | |
| 30 Aug 2012 | Not recorded | Clean | |
| 21 Mar 2011 | Not recorded | 483 | View 483 → |
| 20 Mar 2009 | Not recorded | Clean | |
| 21 Nov 2002 | Not recorded | Clean | |
| 21 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Mar 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Christina N Maurino
Investigators
FDA investigators tied to this site in the record.
Amy W Yan-Mai2 insp.
Christina N Maurino2 insp.
Sarah M Forney1 insp.
Jennifer L Custodio1 insp.
Valerie C Reed1 insp.
Jennifer A Bazergui1 insp.
Jennifer Macmillan1 insp.
Jonee J Mearns1 insp.
Lisa Mathew1 insp.
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 606.160(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(a) | 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