Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-02.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Oct 2023 – 2 Nov 2023 | Foods & Cosmetics | Clean | |
| 3 Aug 2022 – 17 Aug 2022 | Foods & Cosmetics | 483 | View 483 → |
| 26 May 2021 – 19 Jul 2021 | Foods & Cosmetics | 483 | View 483 → |
| 12 Mar 2018 | Foods & Cosmetics | Clean | |
| 18 Jun 2014 – 10 Jul 2014 | Foods & Cosmetics | Clean | |
| 11 Mar 2014 – 2 Jun 2014 | Foods & Cosmetics | Clean | |
| 4 May 2010 | Not recorded | 483 | On file |
| 27 Apr 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
State Agency4 insp.
Jesse Ray N Nardone1 insp.
Jesse N Nardone1 insp.
Willy A Orantes1 insp.
Donyel M Jones1 insp.
Jo-Ann C Declement1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.504(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 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 1.506(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Malincho International's 4 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