Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-01-16.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 16 Jan 2025 | Biologics | Clean | |
| 10 Jan 2023 – 11 Jan 2023 | Biologics | Clean | |
| 10 Dec 2019 – 12 Dec 2019 | Biologics | Clean | |
| 8 Aug 2017 – 10 Aug 2017 | Biologics | Clean | |
| 25 Feb 2016 | Biologics | Clean | |
| 31 Mar 2015 – 1 Apr 2015 | Biologics | 483 | View 483 → |
| 13 Feb 2013 – 14 Feb 2013 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Mizanne E Lewis3 insp.
Stacey F Rivette3 insp.
Lura D Baquero1 insp.
Lura D Kelly1 insp.
Randall L Morris1 insp.
Stacey F Allard1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.350(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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