483
BEYOND AIRBEYOND AIR – FDA 483, Sep 23, 2021
Record Details
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.
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ID · 4942c91e-a1e8-48bb-9734-3e8e81bcde09
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