FDA 483 - Murata Vios, Inc. - December 11, 2024

Murata Vios, Inc., a medical device manufacturer in Woodbury, MN, was inspected by the FDA from December 3-11, 2024. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning corrective and preventive actions, design validation, and design verification procedures. These issues indicate a lack of robust controls over product quality and development processes.