FDA 483 - ITI Manufacturing, Inc. - October 28, 2022

ITI Manufacturing, Inc., an initial importer and contract manufacturer in Sugar Land, TX, was inspected by the FDA from October 18-28, 2022. The inspection revealed significant deficiencies in the firm's quality management system, specifically regarding inadequate procedures for corrective and preventive actions and product handling. These issues indicate a lack of established and complete procedures essential for device quality.