Atlas

Form 483

High Road Craft Ice Cream, Inc. Form 483, 2018-07-26

FDA issued a Form 483 to High Road Craft Ice Cream, Inc. on 2018-07-26 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

High Road Craft Ice Cream, Inc. · Marietta, United States · Issued July 26, 2018

Overview

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

26 Jul 2018
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by N'Jere English, Arthur G Hurst

26 Jul 2018
21 CFR 117.165(b)

Process Controls Verif Procedures: Establish Implement

Cited by N'Jere English, Arthur G Hurst

26 Jul 2018
21 CFR 117.37

Sanitary Facilities and Control

Cited by N'Jere English, Arthur G Hurst

Inspected site

HRHigh Road Craft Ice Cream, Inc.Marietta, United States

Inspection team

NEN'Jere English
AGArthur G Hurst

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations1x
21 CFR 117.165(b)Cited across public-safe Form 483 observations1x
21 CFR 117.37Cited 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