FDA 483 - Adimmune Corporation

Adimmune Corporation in Taichung City, Taiwan, received a Form 483 following a Pre-Approval Inspection, citing significant deficiencies across multiple areas. Observations included improper storage of drug products, failure to validate supplier analyses, inadequate preventive maintenance procedures, and numerous instances of staff not adhering to aseptic operation practices and cleaning protocols. These issues indicate a lack of adherence to established procedures and a need for improved quality system controls.