Form 483

Crystal Creamery, Inc. Form 483, 2013-02-28

FDA issued a Form 483 to Crystal Creamery, Inc. on 2013-02-28 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Crystal Creamery, Inc. · Modesto, United States · Issued February 28, 2013

Overview

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

Inspectional observations

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

28 Feb 2013
21 CFR 110.35(a)

Buildings/good repair

Cited by Marissa J Chan, Jessica B Darneille, Jeanmaire Hryshko, Cynthia L Ford

28 Feb 2013
21 CFR 120.7(a)

Hazard analysis - written - elements

Cited by Marissa J Chan, Jessica B Darneille, Jeanmaire Hryshko, Cynthia L Ford

28 Feb 2013
21 CFR 120.8(b)(5)

HACCP plan - corrective action plan not included

Cited by Marissa J Chan, Jessica B Darneille, Jeanmaire Hryshko, Cynthia L Ford

Inspected site

CCCrystal Creamery, Inc.Modesto, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 120.7(a)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 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