Atlas

Form 483

FORNO DE MINAS USA, INC Form 483, 2018-01-31

FDA issued a Form 483 to FORNO DE MINAS USA, INC on 2018-01-31 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

FORNO DE MINAS USA, INC · Deerfield Beach, United States · Issued January 31, 2018

Overview

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

Inspectional observations

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

31 Jan 2018
21 CFR 1.506(a)(1)

Procedures - establish, approve supplier

Cited by Neimar Lopez-Martinez

31 Jan 2018
21 CFR 1.510(b)(1)

Record - translate to English

Cited by Neimar Lopez-Martinez

Inspected site

FDFORNO DE MINAS USA, INCDeerfield Beach, United States

Inspection team

NLNeimar Lopez-Martinez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations1x

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