Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-09.
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 |
|---|---|---|---|
| 6 Dec 2021 – 9 Dec 2021 | Foods & Cosmetics | Clean | |
| 20 Nov 2017 – 22 Nov 2017 | Foods & Cosmetics | Clean | |
| 21 Apr 2016 – 22 Apr 2016 | Foods & Cosmetics | Clean | |
| 15 Apr 2015 – 5 May 2015 | Foods & Cosmetics | 483 | On file |
| 28 Jan 2014 – 29 Jan 2014 | Foods & Cosmetics | Clean | |
| 11 Jan 2012 | Not recorded | Clean | |
| 16 Feb 2011 | Not recorded | 483 | View 483 → |
| 8 Jun 2010 | Not recorded | Clean | |
| 28 May 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Elizabeth P Mayer2 insp.
Karen M Labounty1 insp.
State Agency1 insp.
Amy L Mcintyre1 insp.
Bradley A Servais1 insp.
Christina A Castineyra1 insp.
Shaun M Olson1 insp.
Dacia E Quick1 insp.
Mada A Tautges1 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 | 1x |
| 21 CFR 108.25(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | 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)(15) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PouchTec Industries, LLC'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