Form 483

Patch Orchards, Inc. Form 483, 2012-11-16

FDA issued a Form 483 to Patch Orchards, Inc. on 2012-11-16 with 5 public-safe observations.

483· Form 483 issued5 observations

Patch Orchards, Inc. · Lebanon, United States · Issued November 16, 2012

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.

16 Nov 2012
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by John R Carlson, Jamie S Emerson

16 Nov 2012
21 CFR 120.6(b)

Sanitation monitoring

Cited by John R Carlson, Jamie S Emerson

16 Nov 2012
21 CFR 120.8(b)(4)

HACCP plan - monitoring procedures - none listed

Cited by John R Carlson, Jamie S Emerson

16 Nov 2012
21 CFR 120.8(b)(5)

HACCP plan - corrective action plan not included

Cited by John R Carlson, Jamie S Emerson

16 Nov 2012
21 CFR 120.11(a)(1)

Verification activities - minimum

Cited by John R Carlson, Jamie S Emerson

Inspected site

POPatch Orchards, Inc.Lebanon, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(5)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