FDA 483 - Hanmi Pharma Co., Ltd - July 05, 2022

An FDA inspection of Hanmi Pharm. Co., Ltd., a drug substance manufacturer in Pyeongtaek-si, Gyeonggi-do, Republic of Korea, identified two observations. The firm was cited for an unqualified temperature-controlled storage area for cGMP materials and inadequate procedural controls for handling and documenting in-process materials.