Form 483

Garden-Fresh Foods, Inc. Form 483, 2016-06-10

FDA issued a Form 483 to Garden-Fresh Foods, Inc. on 2016-06-10 with 14 public-safe observations.

483· Form 483 issuedFoods & Cosmetics14 observations

Garden-Fresh Foods, Inc. · Milwaukee, United States · Issued June 10, 2016

Overview

  • 14 public-safe observations are available for this inspection.
  • 14 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.

10 Jun 2016
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Ana E Morales, Alecia L Marson, Boun M Xiong

10 Jun 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Ana E Morales, Alecia L Marson, Boun M Xiong

10 Jun 2016
21 CFR 110.37(b)(5)

Backflow prevention

Cited by Ana E Morales, Alecia L Marson, Boun M Xiong

10 Jun 2016
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Ana E Morales, Alecia L Marson, Boun M Xiong

10 Jun 2016
21 CFR 110.40(a)

Installation and maintenance of equipment (S)

Cited by Ana E Morales, Alecia L Marson, Boun M Xiong

Inspected site

GFGarden-Fresh Foods, Inc.Milwaukee, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 14 observations

The source PDF and 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