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

During an FDA inspection of Koda Bensh Co. Ltd., a medical device manufacturer, conducted on May 20, 2025, several observations were made regarding the company's quality system. The inspection, documented on an FDA Form 483, highlighted significant deficiencies in the firm's Corrective and Preventive Action (CAPA) processes and complaint handling. Key issues included a lack of documented evidence that customers impacted by CAPA 24-022 received the correct software version to resolve the identified problem. Furthermore, the company's CAPA procedure (FA008) was found to be insufficient, as it did not require records of CAPA activities, such as supplier corrective actions, details of affected products, or customer communications, to be maintained with the main CAPA record. For example, CAPA 24-010 omitted these essential references. Additionally, while Koda Bensh Co. Ltd. conducted a root cause analysis for Complaint 2024-001, the subsequent corrective actions, including procedure updates, were not formally initiated as a CAPA. This omission contradicts the requirements outlined in their own Complaint (FA007) and CAPA (FA008) procedures. To achieve compliance with medical device regulations under the Federal Food, Drug and Cosmetic Act, Koda Bensh Co. Ltd. must enhance its documentation practices, strengthen its CAPA system, and ensure consistent adherence to its internal quality procedures.