Atlas

Form 483

Garden-Fresh Foods, Inc. Form 483, 2014-09-02

FDA issued a Form 483 to Garden-Fresh Foods, Inc. on 2014-09-02 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Garden-Fresh Foods, Inc. · Milwaukee, United States · Issued September 2, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

2 Sep 2014
21 CFR 110.40(a)

Installation and maintenance of equipment (S)

Cited by Eric A Breselow, Nicole C Shokatz, Boun M Xiong

2 Sep 2014
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Eric A Breselow, Nicole C Shokatz, Boun M Xiong

Inspected site

GFGarden-Fresh Foods, Inc.Milwaukee, United States

Inspection team

EAEric A Breselow
NCNicole C Shokatz
BMBoun M Xiong

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)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