Form 483

Brunkow Cheese of Wisconsin, Inc. Form 483, 2011-02-25

FDA issued a Form 483 to Brunkow Cheese of Wisconsin, Inc. on 2011-02-25 with 11 public-safe observations.

483· Form 483 issued11 observations

Brunkow Cheese of Wisconsin, Inc. · Darlington, United States · Issued February 25, 2011

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

25 Feb 2011
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Justin A Boyd, Brian L Szcyubialka, Peter T Erlandson, Kailas Nagaraj

25 Feb 2011
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Justin A Boyd, Brian L Szcyubialka, Peter T Erlandson, Kailas Nagaraj

25 Feb 2011
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Justin A Boyd, Brian L Szcyubialka, Peter T Erlandson, Kailas Nagaraj

25 Feb 2011
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Justin A Boyd, Brian L Szcyubialka, Peter T Erlandson, Kailas Nagaraj

25 Feb 2011
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Justin A Boyd, Brian L Szcyubialka, Peter T Erlandson, Kailas Nagaraj

Inspected site

BCBrunkow Cheese of Wisconsin, Inc.Darlington, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
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 110.10(b)(8)Cited across public-safe Form 483 observations1x
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)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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