Loading…
Kingdom Creamery of Vermont LLC, a ready-to-eat dairy product manufacturer, violated Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls regulations under 21 CFR Part 117 during an August 2024 FDA inspection. FDA investigators detected Listeria monocytogenes, a human pathogen, in environmental swabs collected from the facility's processing areas, rendering the facility's ice cream and frozen yogurt mix bases adulterated and potentially injurious to health. The inspection identified serious deviations in sanitary conditions and preventive controls that were documented on FDA Form 483, with the company's subsequent corrective action responses deemed insufficient to address FDA's ongoing concerns.