FDA 483 - Channel Medsystems, Inc. - February 01, 2019

An FDA inspection of Channel Medsystems, Inc. in Emeryville, CA, revealed significant issues with design verification for their PMA Cerene Cryotherapy Device. The firm failed to confirm that design output met input requirements, as evidenced by multiple device failures during a product performance qualification study and incomplete root cause investigations. Additionally, procedures for design verification were found inadequate due to insufficient shelf life studies covering all validated sterilization cycles.