Form 483

Baldor Specialty Foods, Inc Form 483, 2017-04-07

FDA issued a Form 483 to Baldor Specialty Foods, Inc on 2017-04-07 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Baldor Specialty Foods, Inc · Bronx, United States · Issued April 7, 2017

Overview

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

Inspectional observations

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

7 Apr 2017
21 CFR 110.37(b)(3)

As source of contamination

Cited by Milan S Mcgorty, Christine M Rivera, Ashley Polizzotto

7 Apr 2017
21 CFR 117.40

Equipment and Utensils - Design and Maintenance

Cited by Milan S Mcgorty, Christine M Rivera, Ashley Polizzotto

7 Apr 2017
21 CFR 117.80(b)(2)

Raw Materials Control - Treatment for Microorganisms

Cited by Milan S Mcgorty, Christine M Rivera, Ashley Polizzotto

7 Apr 2017
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by Milan S Mcgorty, Christine M Rivera, Ashley Polizzotto

7 Apr 2017
21 CFR 117.80(a)

Plant Operations - precautions

Cited by Milan S Mcgorty, Christine M Rivera, Ashley Polizzotto

Inspected site

BSBaldor Specialty Foods, IncBronx, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)Cited across public-safe Form 483 observations1x
21 CFR 117.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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