FDA WARNING_LETTER - Sassy Cow Creamery, LLC - June 04, 2019

On December 4, 2019, the FDA issued a Warning Letter to Sassy Cow Creamery, LLC, following an inspection from May 22 to June 4, 2019. The inspection was prompted by a recall of Bourbon Honey Pecan Ice Cream mislabeled as "Gluten Free Cookies N Cream."

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), deeming the ice cream adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Allergen Controls:** Failure to implement preventive controls for undeclared allergens, specifically packaging Bourbon Honey Pecan Ice Cream into "Gluten Free Cookies N Cream" containers, leading to an undeclared tree nut allergen and a Class I Recall. (21 CFR 117.135(a)(1) and (c)(2)) 2. **Sanitation Controls:** Inadequate implementation of sanitation preventive controls for environmental pathogens like *Listeria monocytogenes*. * Failure to document verification of chemical concentrations used during sanitation. * Failure to document or observe required (b)(4) checks of equipment and facility. (21 CFR 117.135(a)(1) and (