Form 483

Brunkow Cheese of Wisconsin, Inc. Form 483, 2022-03-09

FDA issued a Form 483 to Brunkow Cheese of Wisconsin, Inc. on 2022-03-09 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Brunkow Cheese of Wisconsin, Inc. · Darlington, United States · Issued March 9, 2022

Overview

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

Inspectional observations

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

9 Mar 2022
21 CFR 117.20(b)

Plant construction and design

Cited by Peter T Erlandson, Tyson J Eldridge-Stedman, Nicholas J Dubrovin

9 Mar 2022
21 CFR 117.35(a)

Sanitary operations - Plant sanitation

Cited by Peter T Erlandson, Tyson J Eldridge-Stedman, Nicholas J Dubrovin

9 Mar 2022
21 CFR 117.35(b)(1)

Cleaning and sanitizing substances - Safe and adequate

Cited by Peter T Erlandson, Tyson J Eldridge-Stedman, Nicholas J Dubrovin

9 Mar 2022
21 CFR 117.35(e)

Sanitation of non-food-contact surfaces - Manner and frequency

Cited by Peter T Erlandson, Tyson J Eldridge-Stedman, Nicholas J Dubrovin

9 Mar 2022
21 CFR 117.80(a)

Plant operations - Precautions

Cited by Peter T Erlandson, Tyson J Eldridge-Stedman, Nicholas J Dubrovin

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 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(e)Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

The full inspection record, as Atlas holds it, 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