FDA 483 - Hanmi Pharma Co., Ltd - August 02, 2024

An FDA inspection of Hanmi Pharm. Co. Ltd. in Pyeongtaek, Gyeonggi, South Korea, a drug substance manufacturer, revealed two significant observations. The firm failed to perform complete analysis of procured materials at appropriate intervals and did not comprehensively test for contamination. Additionally, the company did not fully follow written procedures for monitoring processing steps, specifically failing to thoroughly and timely evaluate quality events and define change effectiveness parameters for a CAPA.