FDA 483 - BEYOND AIR - September 23, 2021

An FDA inspection of BEYOND AIR in Madison, WI, from September 20-23, 2021, revealed that procedures for design validation were not adequately established or implemented. Specifically, the firm's design validation test report for LungFit PH electrode reliability lacked sufficient data to demonstrate that testing units met required continuous NO delivery rates. This indicates a significant issue with the firm's design control processes.