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

An FDA inspection conducted from January 8-10, 2025, at Shanghai Ziquan Beverage Industry Industrial Co., Ltd. revealed significant deviations from regulatory requirements for low-acid canned food manufacturing. The company, a producer of ready-to-eat tea-based beverages, was cited for failing to process products in conformity with its filed scheduled processes. Specifically, the inspection found discrepancies in the sterilizing media used, methods for achieving commercial sterility of equipment and containers, and holding times, all without supporting validation studies to demonstrate efficacy. Furthermore, critical processing and packaging system records, including those for sterilization media flow rate, temperature, and retention times for containers and closures, were inadequately maintained. The firm's computer system, which controls vital process parameters, retained records for only 30 days, lacking the capability for download or comprehensive review. A lack of qualified operating supervision was also noted, as personnel had not completed essential training like Better Process Controls School and were unaware of FDA-filed processes. The firm failed to maintain a deviation log, and consumer complaints regarding product quality (mold, sour taste) were not investigated with involvement from a process authority. These observations highlight a systemic failure to ensure product safety and adherence to established regulatory frameworks, requiring the firm to implement corrective actions to validate its processes, improve record-keeping, and enhance personnel training and oversight.