# FDA 483 - Oxus, Inc. - October 10, 2019

Source: https://www.globalkeysolutions.net/records/483/oxus-inc/76382c5d-1918-419b-bae1-d4d23c33fd68

> FDA 483 for Oxus, Inc. on October 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxus, Inc.
- Inspection Date: 2019-10-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Okul, Inc. in Auburn Hills, MI, a medical device establishment, was issued a Form FDA 483 following an inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the establishment and implementation of corrective and preventive actions (CAPA) and the timely and adequate handling of product complaints. These issues indicate a lack of robust procedures and consistent execution for critical quality processes.

## Related Documents

- [483 - 2013-09-20](https://www.globalkeysolutions.net/records/483/oxus-inc/fb20211d-1df9-4336-97d7-6b74e58913d2)
- [483 - 2016-01-19](https://www.globalkeysolutions.net/records/483/oxus-inc/d56f64aa-08c4-4cc4-8f17-403eb82ff5f8)

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.globalkeysolutions.net/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

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

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