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

An FDA inspection of Oxus America, Inc., a medical device manufacturer of Class II Portable Oxygen Concentrators, was conducted from January 11 to January 19, 2016. This comprehensive Level 2 Quality System Inspection Technique (QSIT) inspection, performed in accordance with the Quality System Regulation and Compliance Program Guidance Manual (CPG) 7382.845, identified multiple deficiencies in the company's quality management system. A five-point FDA 483 was issued, highlighting critical observations. Main issues included the failure to adequately implement design validation and design change procedures, particularly concerning software versions for their Model RS-00500 POC and the assessment of user needs. The firm also exhibited an inadequate procedure for documenting and controlling nonconforming products, lacking clear requirements for non-part related nonconformances and proper segregation of failed devices. Furthermore, Oxus America, Inc. failed to document justification for not reporting certain modifications performed on returned Model RS-00400 units to the FDA, especially those addressing low oxygen purity complaints. An inadequate finished device acceptance procedure was also noted. Company management acknowledged these observations and committed to providing a written response within 15 days detailing their plan for corrective actions.