FDA 483 - Oxus, Inc. - January 19, 2016

Oxus America, Inc. in Auburn Hills, MI, was inspected by the FDA from January 11-19, 2016, revealing significant deficiencies in their quality system. The firm lacked established procedures for design control, nonconforming product, design changes, and finished device acceptance for their Class II Portable Oxygen Concentrators. These issues indicate a failure to adequately control critical aspects of medical device manufacturing and post-market activities.