# FDA 483 - Xodus Medical Inc - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/xodus-medical-inc/104fdd0a-cd12-4763-87e7-a2c7341644b4

> FDA 483 for Xodus Medical Inc on August 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xodus Medical Inc
- Inspection Date: 2019-08-14
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Xodus Medical Inc. in New Kensington, PA, revealed significant quality system deficiencies. The firm failed to adequately review and revalidate processes after changes, properly investigate complaints and Returned Goods Authorizations (RGAs), and control nonconforming products. These issues led to the distribution of devices with unsealed packaging and a lack of documented corrective and preventive actions.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.globalkeysolutions.net/companies/xodus-medical-inc/362e0707-ddeb-4e46-a8fc-808e1178e7a4

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8