Form 483

Cayenne Company, Inc Form 483, 2009-04-19

FDA issued a Form 483 to Cayenne Company, Inc on 2009-04-19 with 6 public-safe observations.

483· Form 483 issued6 observations

Cayenne Company, Inc · Minneapolis, United States · Issued April 19, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 5 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.

19 Apr 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Zachary P Wachlarowicz, Theresa C Klaman

19 Apr 2009
21 CFR 110.37(f)

Contamination of food, contact surfaces, water supplies, etc

Cited by Zachary P Wachlarowicz, Theresa C Klaman

19 Apr 2009
21 CFR 110.37(f)

Odor, attractant for pests, harborage

Cited by Zachary P Wachlarowicz, Theresa C Klaman

19 Apr 2009
21 CFR 110.40(a)

Precluding contaminants

Cited by Zachary P Wachlarowicz, Theresa C Klaman

19 Apr 2009
21 CFR 110.80(b)(1)

Teardown equipment/thorough cleaning

Cited by Zachary P Wachlarowicz, Theresa C Klaman

Inspected site

CCCayenne Company, IncMinneapolis, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(f)Cited across public-safe Form 483 observations2x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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