FDA 483 - Murata Vios Inc. - April 25, 2024

Murata Vios Inc. in Duluth, GA, a medical device manufacturer, was cited with two observations during an FDA inspection from April 23-25, 2024. The inspection revealed deficiencies in document control procedures, including issues with nonconformance reporting and returned material authorization processes. Additionally, the firm failed to adequately establish procedures for device history records for its Vios device.