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

The U.S. Food and Drug Administration (FDA) issued an Inspectional Observations report (Form FDA 483) to Shanghai Ziquan Beverage Industry Industrial Co., Ltd. following an inspection conducted from January 8-10, 12, 2025. The document, addressed to General Manager Yanxin Zhang, outlines significant deviations from regulatory requirements for manufacturing low-acid canned foods, specifically ready-to-eat tea-based beverages. Key observations include the firm's failure to process products in conformity with its filed scheduled processes. Specifically, different sterilizing media and methods for achieving equipment sterility were used without supporting validation studies. The company also lacked validation demonstrating the effectiveness of its implemented sterilization processes and the removal of residual media. A critical factor, product viscosity, was not routinely measured, and there were no validation studies to confirm its control through other formulation parameters. Furthermore, the inspection revealed inadequate record-keeping practices. Critical process control records, such as sterilization media flow rates, temperatures, and retention times for containers and closures, were not maintained or routinely reviewed. The computer system used for process control retained records for only a limited duration, preventing comprehensive review or download. Finally, the FDA noted that personnel operating critical processing systems were not adequately trained or supervised by individuals who had completed an approved processing school. The firm demonstrated a lack of awareness regarding its filed scheduled processes and failed to document or properly investigate consumer complaints (e.g., mold, sour taste) as potential process deviations, neglecting to consult process authorities. Shanghai Ziquan Beverage Industry Industrial Co., Ltd. is required to implement comprehensive corrective actions to address these observations and ensure compliance with food safety regulations.