FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - January 19, 2017

During an inspection from January 16-19, 2017, the FDA issued a Form 483 to Zhejiang Hisun Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient manufacturer in Taizhou City, China. The inspection revealed significant concerns primarily related to data integrity and stability study deficiencies. A key observation highlighted the firm's failure to adhere to Quality Control laboratory control procedures. Despite having received a previous FDA Warning Letter in December 2015 regarding analytical data integrity and submitting an investigation report claiming no similar issues, the current inspection identified numerous unaddressed data integrity breaches. These included the deletion and overwriting of analytical data, and the performance of analyses with audit trails disabled. The FDA's limited review found approximately 23 such instances, with only three having been reported by the company in their earlier investigation. Additionally, the inspection found that labeled storage conditions for an API batch were not justified by stability studies. An Out-of-Specification result for impurities was confirmed, and no supporting stability data existed for the stated expiration date. The firm also transferred samples to non-representative storage conditions after a stability failure. The company is expected to implement comprehensive corrective actions to resolve these serious observations, ensuring compliance with regulatory standards for data integrity and product stability.