Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-20.
At a glance
Inspections
14
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Apr 2023 – 20 Apr 2023 | Foods & Cosmetics | Clean | |
| 19 Feb 2020 – 21 Feb 2020 | Foods & Cosmetics | 483 | View 483 → |
| 8 Nov 2016 – 10 Nov 2016 | Foods & Cosmetics | 483 | View 483 → |
| 13 Nov 2013 – 15 Nov 2013 | Foods & Cosmetics | 483 | View 483 → |
| 14 Sep 2012 | Not recorded | 483 | View 483 → |
| 8 Apr 2011 | Not recorded | 483 | View 483 → |
| 6 Apr 2010 | Not recorded | 483 | View 483 → |
| 3 Sep 2009 | Not recorded | 483 | On file |
| 9 Feb 2007 | Not recorded | Clean | |
| 17 Apr 2006 | Not recorded | Clean | |
| 4 Jun 2005 | Not recorded | Clean | |
| 30 Mar 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2020
21 CFR 117.80(b)(2)
Raw Materials Control - Treatment for Microorganisms
Cited by David A Gonzalez
21 Feb 2020
21 CFR 117.80(c)
Manufacturing, Processing, Packing, Holding - Controls
Cited by David A Gonzalez
Investigators
FDA investigators tied to this site in the record.
Brittany R Laymon2 insp.
Carla R Hinz2 insp.
Manuel A Moreno1 insp.
David A Gonzalez1 insp.
Laura B Kennedy1 insp.
Holly L Sebastian1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 114.89 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | 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