FDA Inspection 1312284 — Wavely Diagnostics, Inc.
The FDA completed an inspection of Wavely Diagnostics, Inc. on April 14, 2026 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23141 | ISO 13485:2016 Clause 7.4.1 | Supplier monitoring and re-evaluation not planned |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |