Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-08.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jul 2025 – 8 Jul 2025 | Biologics | 483 | View 483 → |
| 9 Aug 2022 – 15 Aug 2022 | Biologics | Clean | |
| 23 Aug 2017 – 24 Aug 2017 | Biologics | Clean | |
| 6 Nov 2014 | Biologics | Clean | |
| 17 Jun 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jul 2025
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Celeta S Coves, Maurine Fadlalla
Investigators
FDA investigators tied to this site in the record.
Yvonne C Wilkes2 insp.
Celeta S Coves1 insp.
Maurine Fadlalla1 insp.
Dylan R Jock1 insp.
Arsen Karapetyan1 insp.
Diana L Ayala1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(d) | 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