FDA 483 - Hisun Pharmaceutical Hangzhou Co., Ltd

Hisun Pharmaceutical Hangzhou Co. Ltd. in Fuyang District, Hangzhou, China, was inspected regarding its API and sterile finished dosage drug manufacturing. The inspection revealed significant data integrity issues, including falsified environmental and water monitoring records, and widespread failures in aseptic processing controls. Additionally, the firm demonstrated inadequate quality management oversight, insufficient cleaning procedures, and a lack of thorough investigations.