# FDA 483 - Ventec Life Systems, Inc. - December 17, 2025

Source: https://www.keypedia.com/records/483/ventec-life-systems-inc/922d95fb-506a-4af6-9fec-de398713c7e2

> FDA 483 for Ventec Life Systems, Inc. on December 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ventec Life Systems, Inc.
- Inspection Date: 2025-12-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Ventec Life Systems, Inc. in Bothell, WA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for timely complaint handling and processing. Additionally, device history records for the VOCSN Unified Respiratory System did not include or refer to primary identification labels, indicating a lack of adherence to manufacturing requirements.

## Related Documents

- [483 - 2021-05-12](https://www.keypedia.com/records/483/ventec-life-systems-inc/6088e4f1-13c1-490d-9983-4cb811da3865)
- [483 - 2022-07-27](https://www.keypedia.com/records/483/ventec-life-systems-inc/7dd1ea47-f29d-42eb-9cac-fef11347a111)

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

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

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