FDA-Inspected Site

MONTEBIANCO USA, LLC

5 FDA inspections are on record for MONTEBIANCO USA, LLC in Hialeah, United States.

Clean· No action indicated

Hialeah, United States · Last updated July 9, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-09-30.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Sep 2022 – 30 Sep 2022Foods & CosmeticsClean
30 Mar 2021 – 13 Apr 2021Foods & Cosmetics483On file
17 Feb 2020Foods & CosmeticsClean
16 Oct 2017 – 19 Oct 2017Foods & Cosmetics483View 483 →
29 Nov 2012Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

19 Oct 2017
21 CFR 117.20(b)

Plant Construction and Design

Cited by Marinee Flores-Marrero

19 Oct 2017
21 CFR 117.20(b)

Plant Construction and Design

Cited by Marinee Flores-Marrero

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 117.20(b)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind MONTEBIANCO USA, 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