FDA 483 - Enthermics Medical Systems, Inc. - July 17, 2025

An FDA inspection of Enthermics Medical Systems, Inc. in Menomonee Falls, WI, a contract manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for in-process product acceptance, corrective and preventive actions, device history records, and control of non-conforming products. These issues indicate a lack of robust quality controls for their medical device manufacturing processes.