FDA 483 - ST Pharm Co., Ltd. - November 05, 2018

ST Pharm Co., Ltd. in Siheung-si, Gyeonggi-do, S. Korea, an API drug manufacturer, was inspected and cited for significant deficiencies in process validation, particularly for water manufacturing. The inspection also revealed incomplete investigations into unexplained discrepancies, lacking thorough root cause analysis and preventative actions. Furthermore, the firm's laboratory controls for handling out-of-specification results were found to be scientifically unsound, permitting retesting without clear procedures or reporting guidelines.