Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-07.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Aug 2025 | Biologics | Clean | |
| 24 Jul 2023 – 25 Jul 2023 | Biologics | Clean | |
| 13 May 2019 – 14 May 2019 | Biologics | 483 | View 483 → |
| 15 May 2017 – 17 May 2017 | Biologics | 483 | View 483 → |
| 1 Jun 2015 | Biologics | Clean | |
| 17 Jun 2013 – 18 Jun 2013 | Biologics | Clean | |
| 23 Jun 2011 | Not recorded | Clean | |
| 16 Jun 2009 | Not recorded | Clean | |
| 25 May 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2017
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Susan M Miller
Investigators
FDA investigators tied to this site in the record.
Cody D Rickman1 insp.
Mizanne E Lewis1 insp.
Esther A Ofori1 insp.
La-Tasha M Gunter1 insp.
Susan M Miller1 insp.
Marlene L Davis1 insp.
Laurie A Haxel1 insp.
Luis A Carrion1 insp.
William F Lagud1 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 | 3x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(c)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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