Form 483

Big Daddy's Creamery LLC dba Theno's Dairy Form 483, 2010-04-27

FDA issued a Form 483 to Big Daddy's Creamery LLC dba Theno's Dairy on 2010-04-27 with 6 public-safe observations.

483· Form 483 issued6 observations

Big Daddy's Creamery LLC dba Theno's Dairy · Redmond, United States · Issued April 27, 2010

Overview

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

27 Apr 2010
21 CFR 110.20(a)(1)

Harborage areas

Cited by Katherine L Arnold

27 Apr 2010
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Katherine L Arnold

27 Apr 2010
21 CFR 110.20(b)(7)

Screening

Cited by Katherine L Arnold

27 Apr 2010
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Katherine L Arnold

27 Apr 2010
21 CFR 110.37(b)(3)

As source of contamination

Cited by Katherine L Arnold

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(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 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