FDA 483 - Alliance Tech Medical, Inc

Alliance Tech Medical, Inc. in Granbury, TX, a device manufacturer, received a Form FDA 483 with three observations. The inspection revealed deficiencies in the firm's complaint handling processes, including inadequate documentation for uninvestigated complaints and a failure to investigate complaints involving potential device failures. Additionally, the firm did not submit a required written report to the FDA concerning a corrective action for a product quality issue.