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, China, was cited for significant deviations from its filed scheduled processes and a lack of proper validation studies. The inspection revealed inadequate record-keeping for critical processing parameters and a severe deficiency in personnel qualifications, as no operators had completed the required Better Process Controls School. These issues, coupled with unaddressed consumer complaints of mold and sour taste, indicate a high risk of product contamination and potential public health hazards.