FDA 483 - Nanjing Hanxin Pharmaceutical Technology Co., Ltd. - March 28, 2025

Nanjing Hanxin Pharmaceutical Technology Co., Ltd. in Nanjing City, China, was cited for significant deficiencies in quality unit oversight, environmental controls, water system monitoring, and batch record documentation during an FDA inspection. The firm distributed API without proper validation and stability data, failed to adequately monitor cleanroom environments for microbial contamination, and had issues with water quality control and investigation of deviations in batch production. These issues indicate a serious lack of control over API manufacturing processes, particularly for products intended for sterile drug use.