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


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.