Form 483

Apple Valley Orchards, LLC. Form 483, 2013-10-30

FDA issued a Form 483 to Apple Valley Orchards, LLC. on 2013-10-30 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Apple Valley Orchards, LLC. · Cleveland, United States · Issued October 30, 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.

30 Oct 2013
21 CFR 110.20(b)(1)

Sufficient space

Cited by Brandon C Heitmeier

30 Oct 2013
21 CFR 120.6(b)

Sanitation monitoring

Cited by Brandon C Heitmeier

30 Oct 2013
21 CFR 120.8(b)(1)

HACCP plan - food hazards not listed

Cited by Brandon C Heitmeier

30 Oct 2013
21 CFR 120.8(b)(3)

HACCP plan - critical limits not listed or not adequate

Cited by Brandon C Heitmeier

30 Oct 2013
21 CFR 120.11(b)

HACCP plan - not validated

Cited by Brandon C Heitmeier

Inspected site

AVApple Valley Orchards, LLC.Cleveland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.12(a)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(3)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