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PT Dua Kelinci, an Indonesian manufacturer of ready-to-eat confectioneries and snack foods, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR Part 117. During an August 2023 inspection, FDA investigators found that the company failed to maintain clean and sanitary plant conditions, including washing production utensils and equipment in visibly dirty water without proper sanitization, which resulted in RTE food products being deemed adulterated and potentially contaminated with filth or injurious to health. The company submitted a response in September 2023 describing corrective actions, but FDA determined the violations were serious enough to warrant formal enforcement action.