Form 483

High Road Craft Ice Cream, Inc. Form 483, 2017-06-30

FDA issued a Form 483 to High Road Craft Ice Cream, Inc. on 2017-06-30 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

High Road Craft Ice Cream, Inc. · Marietta, United States · Issued June 30, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 5 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Jun 2017
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Anthony S Puckett, Simone E Hollis, Lawrence Thomas, Simone M Edmonson, Simone M Edmonson-Hollis

30 Jun 2017
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Anthony S Puckett, Simone E Hollis, Lawrence Thomas, Simone M Edmonson, Simone M Edmonson-Hollis

30 Jun 2017
21 CFR 110.37(b)(5)

Backflow prevention

Cited by Anthony S Puckett, Simone E Hollis, Lawrence Thomas, Simone M Edmonson, Simone M Edmonson-Hollis

Inspected site

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

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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