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Talk to a SpecialistTalk to a SpecialistBarsotti Juice Company's organic carrot juice processing facility violated FDA juice HACCP regulations (21 CFR Part 120) and Current Good Manufacturing Practice standards during an inspection conducted in November and December 2023. The company failed to implement adequate pathogen control measures in its HACCP plan to achieve the required 5-log reduction in resistant microorganisms for the product's shelf life, rendering the juice adulterated and potentially injurious to health. Despite the company's December 2023 response submitting documentation and photographs addressing the FDA's Form 483 observations, the FDA maintained serious concerns about the adequacy of the facility's HACCP program.