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Liberty Fruit Co. Inc. DBA Carol's Cuts manufactured 100% juices under insanitary conditions without adequate Hazard Analysis and Critical Control Point (HACCP) controls, violating 21 CFR Part 120. The company failed to validate its HACCP plan when it made formulation changes to three juice products (Tangy Turmeric, Smooth Avocado, and others) in December 2021, leaving it unclear whether the High Pressure Processing critical limits could achieve the required 5-log pathogen reduction. This validation failure rendered the juice products adulterated and potentially injurious to health. The FDA inspection was conducted between November 7 and December 2, 2022 at the facility in Kansas City, Kansas.