Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-23.
At a glance
Inspections
10
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2026 – 23 Apr 2026 | Biologics | 483 | View 483 → |
| 9 Oct 2024 – 17 Oct 2024 | Biologics | 483 | On file |
| 6 Nov 2023 – 10 Nov 2023 | Biologics | 483 | On file |
| 9 Nov 2022 – 18 Nov 2022 | Biologics | 483 | On file |
| 19 Nov 2019 – 26 Nov 2019 | Biologics | 483 | On file |
| 10 Apr 2018 – 19 Apr 2018 | Biologics | 483 | On file |
| 9 Aug 2016 – 18 Aug 2016 | Biologics | 483 | On file |
| 15 Jul 2014 – 23 Jul 2014 | Biologics | 483 | On file |
| 28 Feb 2011 | Not recorded | Clean | |
| 31 Jan 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2026
21 CFR 211.56(b)
Written sanitation procedures lacking
Cited by Priscilla M Pastrana, Richard L Bartlett
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry3 insp.
Omotunde O Osunsanmi2 insp.
Susan M Jackson2 insp.
Priscilla M Pastrana1 insp.
Richard L Bartlett1 insp.
Unnee Ranjan1 insp.
Jie He1 insp.
Jianyang Wang1 insp.
Kevin J Matthews1 insp.
Ronit Jolles-Mazor1 insp.
Lewis K Antwi1 insp.
Brentley S Collins1 insp.
Jacqueline M Diaz Albert1 insp.
Scott E Norris1 insp.
Simone E Pitts1 insp.
Tracy R Ball1 insp.
Deborah M Trout1 insp.
Joyce A Rockwell1 insp.
Nicole K Trudel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 8 Form 483s
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