FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

An FDA inspection of Lianyungang Hongchuang Pharmaceutical Co. Ltd. in Lianyungang, China, an API manufacturer, revealed significant deficiencies. Observations included manufacturing equipment with corrosion and chipped surfaces, which is used for sterile injectable drug products. Additionally, the firm's Master Batch Records lacked complete instructions for critical production steps.