Form 483

Apple Valley Orchards, LLC. Form 483, 2010-09-24

FDA issued a Form 483 to Apple Valley Orchards, LLC. on 2010-09-24 with 12 public-safe observations.

483· Form 483 issued12 observations

Apple Valley Orchards, LLC. · Cleveland, United States · Issued September 24, 2010

Overview

  • 12 public-safe observations are available for this inspection.
  • 11 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.

24 Sep 2010
21 CFR 110.20(a)(1)

Harborage areas

Cited by Lindsay H Bertling

24 Sep 2010
21 CFR 120.6(a)

Sanitation SSOP - none or not implemented

Cited by Lindsay H Bertling

24 Sep 2010
21 CFR 120.6(b)

Sanitation monitoring

Cited by Lindsay H Bertling

24 Sep 2010
21 CFR 120.6(c)

SSOP records

Cited by Lindsay H Bertling

24 Sep 2010
21 CFR 120.7(c)

All hazards not considered

Cited by Lindsay H Bertling

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 120.8(b)(6)Cited across public-safe Form 483 observations2x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 120.12(a)Cited across public-safe Form 483 observations1x
21 CFR 120.12(c)Cited across public-safe Form 483 observations1x
21 CFR 120.6(a)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.6(c)Cited across public-safe Form 483 observations1x
21 CFR 120.7(c)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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