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

Source: https://www.keypedia.com/records/483/oxus-inc/d56f64aa-08c4-4cc4-8f17-403eb82ff5f8

> FDA 483 for Oxus, Inc. on January 19, 2016. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Oxus, Inc.
- Inspection Date: 2016-01-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Documents

- [483 - 2013-09-20](https://www.keypedia.com/records/483/oxus-inc/fb20211d-1df9-4336-97d7-6b74e58913d2)
- [483 - 2019-10-10](https://www.keypedia.com/records/483/oxus-inc/76382c5d-1918-419b-bae1-d4d23c33fd68)

## Related Officers

- [investigator](https://www.keypedia.com/people/sargum-c-sood/980cd904-0fac-488d-8ea9-39a44d8ea21d)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0