Form 483

Cookies-n-Milk, LLC Form 483, 2012-04-02

FDA issued a Form 483 to Cookies-n-Milk, LLC on 2012-04-02 with 3 public-safe observations.

483· Form 483 issued3 observations

Cookies-n-Milk, LLC · Mckinney, United States · Issued April 2, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

2 Apr 2012
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by David P Rice

2 Apr 2012
21 CFR 110.35(b)(1)

Safe and adequate for use

Cited by David P Rice

2 Apr 2012
21 CFR 110.40(a)

Materials and workmanship

Cited by David P Rice

Inspected site

CLCookies-n-Milk, LLCMckinney, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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