FDA 483 - SHIBUYA CORPORATION - February 01, 2024

An FDA inspection of Shibuya Corporation, a device manufacturer in Kanazawa, Japan, revealed significant issues with their quality system. The firm failed to adequately establish procedures for Corrective and Preventive Action (CAPA) and did not properly control products that did not conform to specifications. These deficiencies indicate a need for improved quality management practices to ensure product safety and effectiveness.