FDA 483 - TZ Medical, Inc. - October 20, 2023

An FDA inspection of TZ Medical, Inc. in Tualatin, OR, a manufacturer of medical devices, revealed a significant quality system deficiency. The firm's procedures for finished device acceptance were not adequately established, leading to the release of sterile defibrillation pads without ensuring complete sterility test results were received and reviewed. This indicates a failure in critical product release controls.