FDA 483 - Sinsin Pharmaceutical Co., Ltd. - December 13, 2019

Sinsin Pharmaceutical Co., Ltd. in Ansan-Si, Gyeonggi-Do, Korea, a drug product manufacturer, was cited for significant deficiencies in quality control, data integrity, and equipment cleaning during an FDA inspection. The firm failed to thoroughly investigate discrepancies and complaints, maintain secure electronic data systems, and adequately document equipment cleaning, with some issues being repeat observations. These findings indicate a serious lack of adherence to cGMP regulations.