FDA 483 - Texas Medical Technology Inc. - March 03, 2022

An FDA inspection of Texas Medical Technology Inc. in Houston, TX, revealed numerous deficiencies in their quality system for manufacturing surgical gowns. The firm lacked adequate procedures for vendor qualification, process validation, device master records, device history records, process controls, statistical techniques, labeling, corrective/preventive actions, and medical device reporting. These findings indicate significant non-compliance with regulatory requirements for medical device manufacturing.