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

Source: https://www.keypedia.com/records/eir/oxus-inc/ab7dce9c-9dd6-445b-a61d-29d189dbbb17

> FDA EIR for Oxus, Inc. on January 19, 2016. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Oxus, Inc.
- Inspection Date: 2016-01-19
- Product Type: devices
- Office Name: Detroit District Office
- Summary: 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.

## Related Documents

- [483 - 2013-09-20](https://www.keypedia.com/records/483/oxus-inc/fb20211d-1df9-4336-97d7-6b74e58913d2)
- [483 - 2016-01-19](https://www.keypedia.com/records/483/oxus-inc/d56f64aa-08c4-4cc4-8f17-403eb82ff5f8)
- [483 - 2019-10-10](https://www.keypedia.com/records/483/oxus-inc/76382c5d-1918-419b-bae1-d4d23c33fd68)
- [EIR - 2019-10-10](https://www.keypedia.com/records/eir/oxus-inc/5fb71c17-11cf-4868-8546-633bf62262ca)

## Related Officers

- [investigator](https://www.keypedia.com/people/sargum-c-sood/980cd904-0fac-488d-8ea9-39a44d8ea21d)
- [issuing_officer](https://www.keypedia.com/people/jeene-d-bailey/e0fc091b-6d0d-4824-bcd1-d557df887a45)

Company: https://www.keypedia.com/companies/oxus-inc/3fe719af-2bb0-4264-8024-b751243ae8f3

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03