# FDA 483 - Avox Systems Inc - February 02, 2024

Source: https://www.globalkeysolutions.net/records/483/avox-systems-inc/b4aace75-0580-4d9d-a2c4-2e6798f32a3b

> FDA 483 for Avox Systems Inc on February 02, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avox Systems Inc
- Inspection Date: 2024-02-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Avox Systems Inc, a medical device manufacturer in Lancaster, NY, was cited with two observations during an FDA inspection. The inspection revealed issues with the provision of Unique Device Identification (UDI) information for their O2 Pak portable oxygen generator and a lack of validation for a critical manufacturing process. The process validation issue was noted as a repeat observation from a previous inspection.

## Related Documents

- [483 - 2021-08-16](https://www.globalkeysolutions.net/records/483/avox-systems-inc/d23ac633-677e-4926-8989-9d5518e3cf1f)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

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

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