FDA 483 - ST Pharm Co., Ltd. - November 08, 2024

ST Pharm Co., Ltd., an API manufacturer in Siheung-si, Gyeonggi-do, Korea, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written quality agreements for contract testing and stability studies, inadequate validation of test methods for API purity, and poor document control practices. Additionally, the firm failed to adhere to its own GMP training effectiveness procedures.