The Royal Ice Cream Company Inc. – FDA Warning Letter, Feb 22, 2022

On July 28, 2022, the FDA issued a Warning Letter to a ready-to-eat (RTE) ice cream manufacturing facility in Manchester, CT, following an inspection from January 19 to February 22, 2022. 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 during the inspection tested positive for *Listeria monocytogenes* (L. monocytogenes), including on a food-contact surface (filler head) and a stainless-steel table. This, coupled with a 2017 detection of L. monocytogenes and a 2022 retail product sample positive for L. monocytogenes, led the FDA to determine the RTE ice cream products were adulterated. Whole genome sequencing indicated a persistent strain of L. monocytogenes since 2017, suggesting a resident pathogen.

Key violations included: 1. **Inadequate Preventive Controls (21 CFR § 117.135(a)(1)):** The facility failed to implement adequate controls for environmental pathogens like L. monocytogenes, despite its hazard analysis identifying pathogens as requiring control. The hazard analysis also incorrectly stated pathogens were unlikely to grow in freezers, where RTE products were exposed. 2. **Inadequate Sanitation Controls (21