FDA 483 - Levo Medical Corporation - May 15, 2024

An FDA inspection of Levo Medical Corporation, a medical device manufacturer in Victoria, identified significant deficiencies in their quality system. The firm's procedures for management review were found to be inadequately established, specifically lacking clear definitions for required management members. Additionally, procedures for complaint handling, including the definition of key terminology essential for medical device reporting, were not adequately established, and adverse event reportability evaluations were poorly documented.