Form 483

Kosher First LLC Form 483, 2014-09-29

FDA issued a Form 483 to Kosher First LLC on 2014-09-29 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Kosher First LLC · Brooklyn, United States · Issued September 29, 2014

Overview

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

Inspectional observations

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

29 Sep 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by Milan S Mcgorty, Peter M Trunk, Anthony R Rauert, Milan S Kunajukr

29 Sep 2014
21 CFR 123.6(b)

HACCP plan location

Cited by Milan S Mcgorty, Peter M Trunk, Anthony R Rauert, Milan S Kunajukr

29 Sep 2014
21 CFR 123.6(c)(2)

Critical control points

Cited by Milan S Mcgorty, Peter M Trunk, Anthony R Rauert, Milan S Kunajukr

29 Sep 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Milan S Mcgorty, Peter M Trunk, Anthony R Rauert, Milan S Kunajukr

29 Sep 2014
21 CFR 123.8(a)

Verification - reviewers qualifications

Cited by Milan S Mcgorty, Peter M Trunk, Anthony R Rauert, Milan S Kunajukr

Inspected site

KFKosher First LLCBrooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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