FDA 483 - Avox Systems Inc - August 16, 2021

Avox Systems Inc. in Lancaster, NY, a medical device manufacturer, was inspected by the FDA from 8/11/2021 to 8/16/2021. The inspection revealed significant deficiencies in quality system procedures, including unvalidated processes, inadequate finished device acceptance, missing design history files, and undocumented personnel training. These issues indicate a lack of robust controls over the manufacturing and design of their O2PAK Portable Oxygen Generators.