FDA 483 - Kyowa Pharma Chemical Co Ltd

KYOWA PHARMA CHEMICAL CO, LTD in Toyama, Japan, a manufacturer of Active Pharmaceutical Ingredients, was cited for significant deficiencies across its quality system, facilities, equipment, production controls, and laboratory controls. Issues include inadequate complaint handling, product quality reviews, investigation justifications, cleaning validation, record-keeping, environmental monitoring, and general lab practices. These observations indicate a broad lack of adherence to good manufacturing practices.