FDA 483 - Fukuda Denshi Co., Ltd.

An FDA inspection of Fukuda Denshi Co. Ltd., a medical device manufacturer in Tokyo, Japan, revealed significant deficiencies in their Corrective and Preventive Action (CAPA) procedures. The firm failed to adequately document CAPA effectiveness, maintain complete CAPA records, and initiate CAPAs for identified product issues. These findings indicate a lack of robust quality system controls.