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Panther James LLC, a juice manufacturer in Berkley, Michigan, was cited for serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 120) during an FDA inspection conducted from October 15 to November 2, 2020. The company failed to have and implement a compliant HACCP plan for its raw untreated juice products, which rendered them adulterated and potentially injurious to health as they were prepared, packed, or held under insanitary conditions. Panther James manufactured and distributed both raw untreated juice sold onsite and at multiple retail locations (Royal Oak, Detroit, Plymouth, and Bloomfield Hills), as well as processed juice sold to other business entities, making the scope of the violations significant.