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Talk to a SpecialistTalk to a SpecialistG.N.R. Group Co., LTD., a Thai manufacturer of frozen fruits, vegetables, and coconut juice, failed to implement adequate Hazard Analysis and Critical Control Point (HACCP) systems as required by 21 CFR Part 120, rendering their juice products adulterated. The company did not include control measures in their HACCP plan capable of consistently achieving a 5-log reduction of pertinent microorganisms for the duration of the product's shelf life under normal and moderate abuse storage conditions, as mandated by 21 CFR 120.24(a). The FDA inspection, conducted January 22-23, 2024, identified these serious deviations, and despite the company's February 6, 2024 response to the inspection observations, the violations remained unresolved.