Form 483

Gold'nkrackle, Inc. Form 483, 2008-11-14

FDA issued a Form 483 to Gold'nkrackle, Inc. on 2008-11-14 with 5 public-safe observations.

483· Form 483 issued5 observations

Gold'nkrackle, Inc. · Mangonia Park, United States · Issued November 14, 2008

Overview

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

Inspectional observations

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

14 Nov 2008
21 CFR 110.35(a)

Buildings/good repair

Cited by Linda K Matheny, Lundy H Patrick

14 Nov 2008
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Linda K Matheny, Lundy H Patrick

14 Nov 2008
21 CFR 110.80(a)(1)

Storage

Cited by Linda K Matheny, Lundy H Patrick

14 Nov 2008
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Linda K Matheny, Lundy H Patrick

14 Nov 2008
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Linda K Matheny, Lundy H Patrick

Inspected site

GIGold'nkrackle, Inc.Mangonia Park, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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