FDA WARNING_LETTER - Kingdom Creamery of Vermont LLC - August 27, 2024

On December 26, 2024, the FDA issued a Warning Letter to a ready-to-eat (RTE) dairy product manufacturing facility in East Hardwick, VT, following an inspection from August 6-27, 2024. 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 swabs collected during the inspection tested positive for *Listeria monocytogenes* (L. mono), a human pathogen. This, combined with insanitary conditions, led the FDA to deem the facility's RTE dairy products, including ice cream and frozen yogurt mix bases, adulterated under 21 U.S.C. § 342(a)(4).

The Warning Letter highlighted a recurring issue with L. mono, noting previous detections in 2022, 2023, and 2024 through both FDA and the firm's own testing of environmental swabs and finished products. Whole genome sequencing (WGS) confirmed a persistent strain of L. mono in the facility's environment and products over multiple years, indicating a resident pathogen. This strain was also genetically identical to clinical isolates from 2021 and 2022, suggesting its capability to cause human illness.

Specific CGMP violations included: 1. **Failure to minimize microbial growth