FDA 483 - Shanghai Ziquan Beverage Industrial Co., LTD. - January 12, 2025

Shanghai Ziquan Beverage Industry Industrial Co., Ltd, a manufacturer of low-acid canned tea beverages in Shanghai, was cited for significant deviations from their filed scheduled processes and a lack of validation studies. The inspection also revealed inadequate record-keeping for critical sterilization parameters and a failure to ensure proper training and supervision for processing operators. These issues indicate potential risks to product sterility and quality control.