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Bakkavor Foods USA Inc.'s ready-to-eat facility in Charlotte, North Carolina manufactured dips, soups, salads, burritos, entrées, and seafood products under insanitary conditions where Listeria monocytogenes was detected in environmental samples. The facility violated Current Good Manufacturing Practice (CGMP) and Preventive Controls regulations under 21 CFR Part 117, as well as Seafood HACCP requirements under 21 CFR Part 123, rendering the ready-to-eat products adulterated and potentially injurious to health. These compliance failures occurred across multiple critical areas including hazard analysis, risk-based preventive controls, and HACCP plan implementation and monitoring.