Form 483

Homestead Creamery, Inc. Form 483, 2013-07-03

FDA issued a Form 483 to Homestead Creamery, Inc. on 2013-07-03 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Homestead Creamery, Inc. · Wirtz, United States · Issued July 3, 2013

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

3 Jul 2013
21 CFR 110.20(b)(1)

Sufficient space

Cited by Brian R Yaun

3 Jul 2013
21 CFR 110.35(b)(2)

Storage requirements

Cited by Brian R Yaun

3 Jul 2013
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Brian R Yaun

3 Jul 2013
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Brian R Yaun

3 Jul 2013
21 CFR 110.80

Reasonable precautions

Cited by Brian R Yaun

Inspected site

HCHomestead Creamery, Inc.Wirtz, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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