FDA 483 - FUKUDA DENSHI CO., LTD.

An FDA inspection of Fukuda Denshi Co. Ltd., a medical device manufacturer in Tokyo, Japan, identified two significant observations. The firm was cited for inadequate documentation of Corrective and Preventive Action (CAPA) activities, including communication of updated instructions and adherence to internal procedures. Additionally, the Device History Record (DHR) procedure was found to be deficient as it did not require reassembly and rework records to be included.