Overview
- 16 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-12.
At a glance
Inspections
16
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Sep 2022 – 12 Sep 2022 | Biologics | Clean | |
| 24 Jul 2018 – 26 Jul 2018 | Biologics | Clean | |
| 25 Jul 2018 | Biologics | Clean | |
| 29 Aug 2016 – 1 Sep 2016 | Biologics | Clean | |
| 29 Sep 2015 – 1 Oct 2015 | Biologics | 483 | View 483 → |
| 29 Sep 2015 – 30 Sep 2015 | Biologics | Clean | |
| 11 Sep 2014 – 3 Oct 2014 | Biologics | 483 | View 483 → |
| 11 Sep 2014 – 18 Sep 2014 | Biologics | 483 | On file |
| 1 Aug 2013 – 30 Sep 2013 | Biologics | 483 | On file |
| 25 Jan 2013 | Not recorded | Clean | |
| 10 Aug 2012 | Not recorded | 483 | View 483 → |
| 20 Oct 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Oct 2015
21 CFR 606.60(a)
Maintain and clean equipment
Cited by Brandon L Mariner, Laurissa S Flowers
3 Oct 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Margaret Torres-Vazquez, Linda S Mattingly
3 Oct 2014
21 CFR 211.125(f)
Procedures Written and Followed
Cited by Margaret Torres-Vazquez, Linda S Mattingly
3 Oct 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Margaret Torres-Vazquez, Linda S Mattingly
10 Aug 2012
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Marion W Nadeau, Cherlita A Honeycutt
Investigators
FDA investigators tied to this site in the record.
Brandon L Mariner4 insp.
Linda S Mattingly4 insp.
Margaret Torres-Vazquez3 insp.
Laurissa S Flowers2 insp.
Cherlita A Honeycutt2 insp.
Patricia A Morrow2 insp.
Marion W Nadeau2 insp.
Nancy L Rose2 insp.
Shusheen A Alexander1 insp.
Amanda B Athey1 insp.
Camilla S Smith1 insp.
James T Mccoy1 insp.
Barbara A Gullick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 7 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