Form 483

Cookies-n-Milk, LLC Form 483, 2025-04-07

FDA issued a Form 483 to Cookies-n-Milk, LLC on 2025-04-07 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Cookies-n-Milk, LLC · Mckinney, United States · Issued April 7, 2025

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

7 Apr 2025
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Cristina Alicea Matos

7 Apr 2025
21 CFR 117.405(a)(1)

Supply-chain program - Implement

Cited by Cristina Alicea Matos

Inspected site

CLCookies-n-Milk, LLCMckinney, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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