FDA WARNING_LETTER - Cookies-n-Milk, LLC - October 19, 2023

The FDA inspected Cookies-n-Milk's RTE cookie dough facility in McKinney, TX, from October 3-19, 2023, following a Class 1 recall of Chocolate Chip Edible Cookie Dough due to undeclared peanuts from incorrect packaging. The inspection revealed serious violations of the CGMP and PC rule (21 CFR Part 117).

The facility's RTE Peanut Butter Cup Edible Cookie Dough was misbranded under 21 U.S.C. § 343(w) for failing to declare peanuts as a major food allergen, and under 21 U.S.C. § 343(i)(2) for failing to declare all common or usual names of ingredients (milk powder, baking soda, and salt).

Significant violations included: 1. **Hazard Analysis Deficiencies (21 CFR 117.130(a)(1))**: * Failure to identify and evaluate undeclared allergens due to incorrect labeling as a hazard requiring a preventive control at the packaging/labeling step. The firm's investigation confirmed a lack of packaging controls led to the recall. * Failure to identify and evaluate mycotoxins (e.g., aflatoxin) as a hazard requiring a preventive control for peanut butter and peanut butter-containing ingredients, and failure to implement a risk-based supply-chain program with supplier verification activities (2