# FDA 483 - Ventec Life Systems, Inc. - July 27, 2022

Source: https://www.globalkeysolutions.net/records/483/ventec-life-systems-inc/7dd1ea47-f29d-42eb-9cac-fef11347a111

> FDA 483 for Ventec Life Systems, Inc. on July 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ventec Life Systems, Inc.
- Inspection Date: 2022-07-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Ventec Life Systems, Inc. in Bothell, WA, was inspected from July 14-27, 2022, revealing a significant regulatory non-compliance. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe for malfunctions of its VOCSN Unified Respiratory System. These malfunctions were identified as being likely to cause or contribute to death or serious injury if they were to recur.

## Related Documents

- [483 - 2021-05-12](https://www.globalkeysolutions.net/records/483/ventec-life-systems-inc/6088e4f1-13c1-490d-9983-4cb811da3865)

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/ventec-life-systems-inc/2f4d0b50-94d9-4ac4-be67-dab3cf0a2cb4

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822