# FDA 483 - Viper Technologies, LLC dba Avalign Thortex - September 24, 2021

Source: https://www.keypedia.com/records/483/viper-technologies-llc-dba-avalign-thortex/7af5bf9b-b563-4723-806d-ee063fd4fc9e

> FDA 483 for Viper Technologies, LLC dba Avalign Thortex on September 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viper Technologies, LLC dba Avalign Thortex
- Inspection Date: 2021-09-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Viper Technologies, LLC dba Avalign Thortex in Portland, OR, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, complaint handling, and control of nonconforming product. Additionally, issues were identified with the establishment and implementation of device history record procedures, indicating systemic quality management failures.

## Related Officers

- [Rebecca L. Stephany](https://www.keypedia.com/people/rebecca-l-stephany/33f38e32-c0a6-4292-a515-ab3f6ca6503a)
- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/viper-technologies-llc-dba-avalign-thortex/f7cc4d02-fded-4c8a-a1bc-f9e522ca8839

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