FDA 483 - Hisun Pharmaceutical Hangzhou Co., Ltd - July 20, 2021

An FDA inspection of Hisun Pharmaceutical Hangzhou Co., Ltd, an API and sterile finished dose drug manufacturer, revealed significant deficiencies in pyrogen control, aseptic processing, and facility sanitation. The firm failed to validate cleaning methods, monitor critical process parameters, and maintain clean conditions, leading to potential microbial contamination, particle generation, and adverse drug events in patients. These issues indicate a serious lack of control over manufacturing processes and facility maintenance.