FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - January 16, 2017

Zhejiang Hisun Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient Manufacturer in Taizhou City, China, was cited for significant data integrity issues in its Quality Control laboratory, including deletion and overwriting of data and running analyses without an audit trail, despite a previous commitment to address such issues. Additionally, the firm failed to justify labeled storage conditions with adequate stability studies, transferring samples to different conditions after an out-of-specification result. These observations indicate serious deficiencies in data management and quality control procedures.