FDA 483 - CO-AX Technology Inc - August 02, 2023

CO-AX Technology Inc, a medical device contract manufacturer in Solon, OH, was inspected by the FDA. The inspection revealed significant deficiencies across its quality system, including unvalidated manufacturing processes, inadequate control over nonconforming product rework, and failures in equipment calibration and complaint handling. The firm also lacked proper procedures for incoming product acceptance, corrective/preventive actions, and supplier controls, indicating a broad need for quality system improvements.