FDA 483 - Quality Aspirators, Inc - April 23, 2025

Quality Aspirators, Inc. in Duncanville, TX, a contract manufacturer of Class 1 and Class 2 medical devices, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in environmental controls, including undocumented pest control and structural issues, as well as inadequate equipment maintenance schedules for manufacturing equipment. These issues indicate a lack of established procedures to ensure product quality and safety.