FDA 483 - Austco Marketing & Service LTD. - September 23, 2022

An FDA inspection of Austco Marketing & Service LTD., a medical device manufacturer in Irving, TX, from September 19-23, 2022, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling, internal audits, supplier control, and corrective and preventive actions. These issues indicate a systemic breakdown in maintaining a compliant quality management system.