Form 483

Patch Orchards, Inc. Form 483, 2018-11-14

FDA issued a Form 483 to Patch Orchards, Inc. on 2018-11-14 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Patch Orchards, Inc. · Lebanon, United States · Issued November 14, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

14 Nov 2018
21 CFR 117.35(b)(1)

Cleaning and sanitizing substances- safe and adequate

Cited by Richard F Hapke

14 Nov 2018
21 CFR 117.40

Equipment and Utensils - Design and Maintenance

Cited by Richard F Hapke

14 Nov 2018
21 CFR 120.6(b)

GMP correction - timely

Cited by Richard F Hapke

Inspected site

POPatch Orchards, Inc.Lebanon, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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