# FDA 483 - Avox Systems Inc - August 16, 2021

Source: https://www.keypedia.com/records/483/avox-systems-inc/d23ac633-677e-4926-8989-9d5518e3cf1f

> FDA 483 for Avox Systems Inc on August 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avox Systems Inc
- Inspection Date: 2021-08-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Avox Systems Inc. in Lancaster, NY, a medical device manufacturer, was inspected by the FDA from 8/11/2021 to 8/16/2021. The inspection revealed significant deficiencies in quality system procedures, including unvalidated processes, inadequate finished device acceptance, missing design history files, and undocumented personnel training. These issues indicate a lack of robust controls over the manufacturing and design of their O2PAK Portable Oxygen Generators.

## Related Documents

- [483 - 2024-02-02](https://www.keypedia.com/records/483/avox-systems-inc/b4aace75-0580-4d9d-a2c4-2e6798f32a3b)

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/avox-systems-inc/a6752801-cf53-4c39-8793-c8f93dc955ed

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961