# FDA 483 - Wavely Diagnostics, Inc. - April 14, 2026

Source: https://www.keypedia.com/records/483/wavely-diagnostics-inc/5916722c-d407-4a74-80cd-f3d914bdea35

> FDA 483 for Wavely Diagnostics, Inc. on April 14, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Wavely Diagnostics, Inc.
- Inspection Date: 2026-04-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Wavely Diagnostics, Inc. in Seattle, WA, a specification developer for the Class II Wavely Middle Ear Fluid Scanner, revealed significant deficiencies in their quality system. Observations included inadequate software validation documentation, failure to conduct internal audits at planned intervals, and insufficient planning and execution of supplier monitoring and quality agreements for critical outsourced processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/wavely-diagnostics-inc/6430dfba-93ce-4d53-9002-0d593f9c00c4

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