# FDA 483 - CurvaFix, Inc. - August 23, 2023

Source: https://www.keypedia.com/records/483/curvafix-inc/0bf25974-1fdb-4322-8a0b-e113f52ae84c

> FDA 483 for CurvaFix, Inc. on August 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CurvaFix, Inc.
- Inspection Date: 2023-08-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of CurvaFix, Inc. in Bellevue, WA, a manufacturer of Class 2 medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for medical device reporting, quality audits, corrective and preventive actions, and supplier management. Additionally, issues were noted with the justification for not reporting correction/removal actions and the statistical rationale for sampling plans.

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## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)
- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/curvafix-inc/cae6af63-f35e-42fc-9640-8896a3420fe3

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