FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd - April 24, 2026

Jiangsu Hansoh Pharmaceutical Group Co. Ltd. in Lianyungang, Jiangsu, was inspected regarding its sterile drug manufacturing operations. The inspection revealed significant deficiencies across multiple areas, including inadequate validation of sterilization processes, insufficient investigation into discrepancies and complaints, and failures in environmental monitoring and equipment calibration. These issues indicate a lack of robust controls to prevent microbiological contamination and ensure product quality and sterility.