FDA 483 - Xenobiotic Laboratories, Inc. - March 28, 2025

An FDA inspection of WuXi AppTec Co., Ltd. (doing business as Xenobiotic Laboratories) in Plainsboro, NJ, revealed a significant issue regarding the firm's adherence to its Standard Operating Procedures (SOPs) for reinjection of analytical runs. Specifically, the firm failed to follow established protocols for reinjecting samples during method validation and study sample analysis, leading to the improper reinjection of entire runs instead of specific missed or failing samples. This indicates a deviation from internal quality control procedures in a biopharmaceutical analytical facility.