Form 483

Garden-Fresh Foods, Inc. Form 483, 2013-07-09

FDA issued a Form 483 to Garden-Fresh Foods, Inc. on 2013-07-09 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Garden-Fresh Foods, Inc. · Milwaukee, United States · Issued July 9, 2013

Overview

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

Inspectional observations

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

9 Jul 2013
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Nicole C Shokatz

9 Jul 2013
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Nicole C Shokatz

9 Jul 2013
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Nicole C Shokatz

9 Jul 2013
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Nicole C Shokatz

9 Jul 2013
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Nicole C Shokatz

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 123.6(c)(1)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)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)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)(i)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