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

Source: https://www.keypedia.com/records/warning_letter/sassy-cow-creamery-llc/90e38fa6-9aeb-402f-881a-942ff5f41e0b

> FDA WARNING_LETTER for Sassy Cow Creamery, LLC on June 04, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sassy Cow Creamery, LLC
- Inspection Date: 2019-06-04
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West I
- Summary: 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 (

## Related Officers

- [Boun M. Xiong](https://www.keypedia.com/people/boun-m-xiong/2c83752d-efe2-4c8e-922f-7ffe135ab017)
- [Acting Assistant Commissioner](https://www.keypedia.com/people/michael-dutcher/5e9981f8-673f-4a2c-a0b5-dd5e8e8de1f4)

Company: https://www.keypedia.com/companies/sassy-cow-creamery-llc/3f15afab-99b1-4992-aff0-74a757b81eac

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-i/1c3129a0-b8fd-4558-9283-44531498dbdd