# FDA 483 - Oxus, Inc. - September 20, 2013

Source: https://www.keypedia.com/records/483/oxus-inc/fb20211d-1df9-4336-97d7-6b74e58913d2

> FDA 483 for Oxus, Inc. on September 20, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxus, Inc.
- Inspection Date: 2013-09-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Oxus America, Inc. in Rochester Hills, MI, revealed a significant issue with device master record maintenance. The firm failed to maintain an approved master specification for primary labels on its Matchbox Oxygen Concentrator medical devices. This indicates a lapse in quality system controls for device labeling.

## Related Documents

- [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)

## Related Officers

- [investigator](https://www.keypedia.com/people/deanna-lampley/e894410f-2d65-4131-bc9a-930bb0b0d574)

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