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Form 483

MONTEBIANCO USA, LLC Form 483, 2017-10-19

FDA issued a Form 483 to MONTEBIANCO USA, LLC on 2017-10-19 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

MONTEBIANCO USA, LLC · Hialeah, United States · Issued October 19, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

MUMONTEBIANCO USA, LLCHialeah, United States

Inspection team

MFMarinee Flores-Marrero

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere