We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Missing Heparin Coating on Tubing Earns Bioptimal FDA Warning Letter
Missing Heparin Coating on Tubing Earns Bioptimal FDA Warning Letter
China-based Bioptimal International removed the heparin coating from the tubing for its thermodilution catheter without seeking FDA clearance for the device, earning the company a Warning Letter following a Nov. 6, 2023, inspection of the company’s Singapore facility.