Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-08.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2024 – 8 Mar 2024 | Foods & Cosmetics | 483 | View 483 → |
| 7 Oct 2019 – 18 Oct 2019 | Foods & Cosmetics | Clean | |
| 16 Apr 2018 – 19 Apr 2018 | Foods & Cosmetics | Clean | |
| 6 Jul 2015 | Foods & Cosmetics | Clean | |
| 21 Jun 2012 | Not recorded | 483 | View 483 → |
| 25 Mar 2009 | Not recorded | Clean | |
| 9 Sep 2008 | Not recorded | Clean | |
| 2 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2024
21 CFR 117.135(a)(1)
Preventive controls - Implement (Limited Scope only)
Cited by Jose Perez-Soto, Karl D Hezel
8 Mar 2024
21 CFR 117.135(c)(2)
Allergen preventive controls - Appropriate (Adequate)
Cited by Jose Perez-Soto, Karl D Hezel
8 Mar 2024
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Jose Perez-Soto, Karl D Hezel
8 Mar 2024
21 CFR 117.405(a)(1)
Supply-chain program - Implement
Cited by Jose Perez-Soto, Karl D Hezel
Investigators
FDA investigators tied to this site in the record.
Eva I Merced Medina2 insp.
Cntrctmntr Pares2 insp.
Jose Perez-Soto1 insp.
Karl D Hezel1 insp.
Michael C Lombardi1 insp.
Pablo Feliciano1 insp.
Juan R Jimenez Garcia1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pan Pepin, Inc.'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