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

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.