FDA 483 - Fukuda Denshi Co. Ltd. Production - April 10, 2025

An FDA inspection of Koda Denshi Co. Ltd., a medical device manufacturer in Tokyo, Japan, was conducted from October 5-10, 202x. The inspection resulted in the issuance of an FDA Form 483, detailing observations of objectionable conditions and practices indicating non-compliance with the Federal Food, Drug, and Cosmetic Act. The primary issues revolved around the company's Corrective and Preventive Action (CAPA) system. Specifically, for CAPA 24-022, there was insufficient documentation to demonstrate that impacted devices received the correct software update. Furthermore, the company's CAPA procedure was found to be inadequate as it did not require records of CAPA activities, such as supplier corrective actions or impacted product information, to be maintained with the corresponding CAPA record. Another observation noted that the firm failed to initiate a CAPA for complaint A00434-001, despite conducting a root cause analysis, which is a requirement of their own Complaint and CAPA procedures. These observations indicate deficiencies in Koda Denshi Co. Ltd.'s quality system, particularly concerning documentation and adherence to established internal procedures for managing complaints and corrective actions for medical devices. The company is expected to address these observations and implement corrective actions to ensure compliance with FDA regulations.