FDA 483 - Enthermics Medical Systems, Inc. - September 16, 2021

Enthermics Medical Systems, Inc. in Menomonee Falls, WI, a medical device manufacturer, was cited for three observations during an FDA inspection. The firm's corrective and preventive action procedures were found to be inadequate, failing to ensure proper identification of actions needed to prevent recurrence of quality issues. Additionally, procedures for acceptance of incoming product were not adequately established, and a validated process was not revalidated after changes occurred.