Form 483

See Rock City, Inc. dba Clumpies Ice Cream Co. Form 483, 2017-07-27

FDA issued a Form 483 to See Rock City, Inc. dba Clumpies Ice Cream Co. on 2017-07-27 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

See Rock City, Inc. dba Clumpies Ice Cream Co. · Chattanooga, United States · Issued July 27, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

27 Jul 2017
21 CFR 110.10(b)(6)

Failure to wear

Cited by Michelle M Fowler-Ogburn, Lawrence A Butler

27 Jul 2017
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Michelle M Fowler-Ogburn, Lawrence A Butler

27 Jul 2017
21 CFR 110.35(d)

Failure to clean - general

Cited by Michelle M Fowler-Ogburn, Lawrence A Butler

27 Jul 2017
21 CFR 110.40(a)

Precluding contaminants

Cited by Michelle M Fowler-Ogburn, Lawrence A Butler

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)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