Form 483

Big Daddy's Creamery LLC dba Theno's Dairy Form 483, 2011-07-18

FDA issued a Form 483 to Big Daddy's Creamery LLC dba Theno's Dairy on 2011-07-18 with 6 public-safe observations.

483· Form 483 issued6 observations

Big Daddy's Creamery LLC dba Theno's Dairy · Redmond, United States · Issued July 18, 2011

Overview

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

18 Jul 2011
21 CFR 110.20(a)(3)

Drainage

Cited by Gerard P De Leon, Katherine L Arnold

18 Jul 2011
21 CFR 110.20(b)(7)

Screening

Cited by Gerard P De Leon, Katherine L Arnold

18 Jul 2011
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Gerard P De Leon, Katherine L Arnold

18 Jul 2011
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Gerard P De Leon, Katherine L Arnold

18 Jul 2011
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Gerard P De Leon, Katherine L Arnold

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)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)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)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