Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-10.
At a glance
Inspections
12
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2019 – 10 Sep 2019 | Foods & Cosmetics | Clean | |
| 10 Aug 2016 – 11 Aug 2016 | Foods & Cosmetics | Clean | |
| 10 Oct 2012 | Not recorded | 483 | View 483 → |
| 31 May 2012 | Not recorded | 483 | View 483 → |
| 13 Jan 2011 | Not recorded | 483 | View 483 → |
| 26 Jan 2010 | Not recorded | 483 | View 483 → |
| 25 Jun 2009 | Not recorded | Clean | |
| 3 Oct 2006 | Not recorded | Clean | |
| 9 Aug 2004 | Not recorded | Clean | |
| 1 Apr 2003 | Not recorded | Clean | |
| 10 Oct 2000 | Not recorded | Clean | |
| 27 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Oct 2012
21 CFR 110.10(b)(9)
Precautions against contamination--micro, foreign substances
Cited by Meredith M Cobb, Ashley Segura
Investigators
FDA investigators tied to this site in the record.
Ashley Segura2 insp.
Robert W Calais1 insp.
Israel Juarbe1 insp.
Ashley B Jelonek1 insp.
Ladislav Kermet1 insp.
Meredith M Cobb1 insp.
Jason D Tenney1 insp.
Lisa A Warner1 insp.
Stephanie C Milan1 insp.
Jose N Santiago1 insp.
Kimberly M Hull1 insp.
Deborah A Racioppi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.12(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.12(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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