FDA Inspection
Wavely Diagnostics, Inc.Wavely Diagnostics, Inc. – FDA Inspection, Apr 14, 2026
Record Details
This FDA Inspection record concerns Wavely Diagnostics, Inc., with an inspection on April 14, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9a3b3138-e566-4f79-b604-952f068b9453
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1312284
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
- ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
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