Overview
- 12 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
12
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 1 Aug 2025 | Biologics | 483 | View 483 → |
| 16 Feb 2023 – 7 Mar 2023 | Biologics | Clean | |
| 18 Jul 2019 – 26 Jul 2019 | Biologics | Clean | |
| 14 Sep 2017 | Biologics | Clean | |
| 17 Oct 2016 – 7 Nov 2016 | Biologics | 483 | View 483 → |
| 7 Jul 2014 – 20 Aug 2014 | Biologics | 483 | View 483 → |
| 21 Jun 2012 | Not recorded | 483 | View 483 → |
| 27 Sep 2011 | Not recorded | 483 | View 483 → |
| 8 Sep 2011 | Not recorded | Clean | |
| 16 Sep 2008 | Not recorded | 483 | On file |
| 23 Nov 2005 | Not recorded | Clean | |
| 1 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2025
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Amy Kim, Amy W Yan-Mai
1 Aug 2025
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Amy Kim, Amy W Yan-Mai
Investigators
FDA investigators tied to this site in the record.
Lorayne A Mcguinness6 insp.
Elizabeth B Griffin3 insp.
Amy Kim1 insp.
Amy W Yan-Mai1 insp.
Mary E Baker-Brown1 insp.
Alice C Silva1 insp.
Kent A Conforti1 insp.
Sherry M Nisson1 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 | 5x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.41 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 6 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