Form 483

BREFARO'S NOBILE FOOD, LLC Form 483, 2010-05-21

FDA issued a Form 483 to BREFARO'S NOBILE FOOD, LLC on 2010-05-21 with 7 public-safe observations.

483· Form 483 issued7 observations

BREFARO'S NOBILE FOOD, LLC · Miami Lakes, United States · Issued May 21, 2010

Overview

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

Inspectional observations

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

21 May 2010
21 CFR 110.35(d)(5)

Safe and adequate for use

Cited by Gabriel E Muniz, Rachel Peters

21 May 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by Gabriel E Muniz, Rachel Peters

21 May 2010
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Gabriel E Muniz, Rachel Peters

21 May 2010
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Gabriel E Muniz, Rachel Peters

21 May 2010
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Gabriel E Muniz, Rachel Peters

Inspected site

BNBREFARO'S NOBILE FOOD, LLCMiami Lakes, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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