Form 483

Big Daddy's Creamery LLC dba Theno's Dairy Form 483, 2009-09-03

FDA issued a Form 483 to Big Daddy's Creamery LLC dba Theno's Dairy on 2009-09-03 with 11 public-safe observations.

483· Form 483 issued11 observations

Big Daddy's Creamery LLC dba Theno's Dairy · Redmond, United States · Issued September 3, 2009

Overview

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

3 Sep 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Katherine L Arnold, Janelle K Martin

3 Sep 2009
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Katherine L Arnold, Janelle K Martin

3 Sep 2009
21 CFR 110.20(a)(1)

Harborage areas

Cited by Katherine L Arnold, Janelle K Martin

3 Sep 2009
21 CFR 110.20(a)(3)

Drainage

Cited by Katherine L Arnold, Janelle K Martin

3 Sep 2009
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Katherine L Arnold, Janelle K Martin

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(3)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(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
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(a)(1)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