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Ice Cream House LLC was warned for manufacturing ready-to-eat ice cream products under insanitary conditions in violation of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls regulations (21 CFR Part 117). FDA inspectors collected environmental samples from the Brooklyn, NY facility between February and March 2024 and detected Listeria monocytogenes, a human pathogen, in multiple areas of the production environment, rendering the products adulterated. The facility's serious CGMP violations included failures in preventive control provisions across multiple regulatory subparts, and the contamination was linked to a multistate Listeria outbreak traced to Ice Cream House products.