FDA 483 - Hanmi Pharma Co., Ltd - June 02, 2021

An FDA inspection of Hanmi Pharm. in Pyeongtaek-si, Republic of Korea, a drug substance manufacturer, revealed ten observations. The findings highlight significant inconsistencies in manufacturing processes, inadequate protocols for process control and validation, and deficiencies in documentation, CAPAs, and process understanding. These issues collectively indicate a lack of robust control over drug substance manufacturing, which could impact product quality.