Company
United StatesWavely Diagnostics, Inc., Seattle, WA – FDA Inspections
Inspection records and compliance data for Wavely Diagnostics, Inc. in Seattle, Washington. 1 FDA inspection on record, last inspected April 14, 2026.
Company Profile
This profile covers Wavely Diagnostics, Inc. based in Seattle, Washington, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected April 14, 2026.
Most cited issue areas
- Design and development validation not performed as planned1 inspection
- External party controls do not include written quality agreements1 inspection
- Internal audits not conducted to ensure QMS meets requirements and is effective1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 14, 2026 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1312284 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Wavely Diagnostics, Inc.
FEI Number
3022527636
Address
2319 N 45th St Ste 107, Seattle, Washington 98103, United States
Country
United States
ID: 6430dfba-93ce-4d53-9002-0d593f9c00c4