FDA WARNING_LETTER - Velvet Ice Cream Company - February 14, 2019

On May 6, 2019, the FDA issued a Warning Letter to Velvet Ice Cream Company, Inc. following an inspection from January 23 to February 14, 2019, at their Utica, Ohio facility. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Environmental samples collected by the FDA tested positive for *Listeria monocytogenes* (L. monocytogenes), including the same strain found during previous 2017 and 2018 inspections. Whole genome sequencing identified 21 isolates representing six different strains, with one strain genetically identical to a 2018 clinical isolate, indicating a resident pathogen. This led the FDA to determine that the ice cream manufactured is adulterated under 21 U.S.C. § 342(a)(4).

Violations included inadequate sanitation controls to prevent environmental pathogens, despite identifying them as a hazard requiring preventive controls (21 CFR §§ 117.135(a)(1) and (c)(3)). The company's own environmental monitoring also repeatedly found *Listeria spp.* Additionally, non-food contact surfaces were not cleaned adequately (21 CFR 117.35(e)), evidenced by overspray contaminating cleaned equipment and ingredients. The facility's design also did