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Talk to a SpecialistTalk to a SpecialistPanjin Hetian Food Co., Ltd., a rice protein powder manufacturer in China, violated Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR Part 117 during an FDA inspection conducted December 1-3, 2020. The facility failed to comply with preventive controls provisions, with the letter indicating specific deficiencies in hazard analysis for ready-to-eat products, though the complete list of violations was cut off in the provided excerpt. The company submitted a response in December 2020 with corrective actions, training records, and sanitation procedures, but the FDA determined these measures were insufficient to address the serious compliance gaps identified at the facility.