FDA 483 - Adimmune Corporation

An FDA inspection of Adimmune Corporation, a biological drug manufacturer in Taichung City, Taiwan, identified two significant observations. The firm's batch records and procedures were found to be inadequate in documenting production instructions and data, including alarm logs and equipment identification. Additionally, automatic equipment used for visual inspection of vaccine products lacked adequate control over its parameters, leading to confusion due to duplicate electronic recipes with differing rejection values.