FDA 483 - Adimmune Corporation

An FDA inspection of Adimmune Corporation, a vaccine manufacturer in Taichung City, Taiwan, revealed significant deficiencies across its operations. The firm was cited for inadequate media simulation and media fill studies, insufficient quality control review of batch records, and incomplete validation of sterilization processes. Other critical issues included improper storage of drug substance, inadequate Quality Unit procedures, incomplete process and equipment validations, and deficiencies in environmental monitoring and testing instructions.