Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-09.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2025 | Foods & Cosmetics | 483 | View 483 → |
| 14 Jan 2025 – 16 Jan 2025 | Foods & Cosmetics | 483 | View 483 → |
| 17 May 2023 – 18 May 2023 | Foods & Cosmetics | 483 | View 483 → |
| 15 Jun 2022 – 24 Jun 2022 | Foods & Cosmetics | WL | View 483 → |
| 12 May 2020 – 13 May 2020 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jan 2025
21 CFR 1.506(a)(1)
Unapproved supplier procedures - importer established
Cited by Gerardo I Martinez
16 Jan 2025
21 CFR 1.506(b)
Supplier verification - follow written procedures
Cited by Gerardo I Martinez
Investigators
FDA investigators tied to this site in the record.
Rosa M Santiago1 insp.
Gerardo I Martinez1 insp.
Luis A Salinas1 insp.
Julianna E Ramos1 insp.
Ronnie Garza1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.502(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.506(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.506(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.505(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Manzela USA, LLC's 5 Form 483s
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