Maker of disinfectant systems for dialysis gets FDA warning

A maker of water disinfectant systems for dialysis has received a warning letter from the FDA for problems at its Kentucky plant. The agency took Tango3 to task for failing to document the design of the ozone system that is supposed to automatically flush the water storage tank and distribution loop of all ozone, endotoxin or biofilm residue at the end of each disinfection cycle, then refill the storage tank for the next scheduled dialysis shift. Among the 16 observations made at the Simpsonville, KY, facility were failures to adequately test the products, and insufficient procedures to review and investigate complaints. FDA warning letter