FDA 483 - SHIBUYA CORPORATION - February 01, 2024

An FDA inspection of Shibuya Corporation, a medical device manufacturer based in Kanazawa, Ishikawa, Japan, took place from January 29 to February 1, 2024. The inspection identified several significant observations documented on a Form FDA 483, indicating deviations from U.S. quality system regulations for medical devices. The primary issues noted were inadequacies in the company's Corrective and Preventive Action (CAPA) procedures and insufficient control over nonconforming products. Specifically, Shibuya Corporation failed to promptly open CAPAs for complaints and manufacturing nonconformances that met internal criteria for such actions. For example, two customer complaints from early 2023, involving issues like a loose cable and a device failing to switch to battery mode, were not addressed with CAPAs until January 2024, despite being identified as requiring them. Additionally, a manufacturing error from October 2023, where an incorrect component was used, lacked an active CAPA to investigate its root cause at the start of the inspection. Furthermore, the inspection revealed deficiencies in controlling products that did not meet specifications. An instance was cited where an incorrect concentration sensor was used in several "Surdial DX" devices. The initial nonconformance record did not adequately track the full scope of affected products. These observations require Shibuya Corporation to implement comprehensive corrective actions to address the identified quality system deficiencies and ensure ongoing compliance with regulatory standards.