FDA 483 - Sinsin Pharmaceutical Co., Ltd. - February 14, 2025

An FDA inspection of Sinsin Pharmaceutical Co., Ltd. in Sejong, Korea, a drug manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate investigations into discrepancies and complaints, failure to follow stability testing programs, lack of component identity verification, and issues with equipment calibration and facility design. These findings indicate a serious lack of control over manufacturing processes and quality assurance.