FDA 483 - WAVi Co. - March 29, 2023

WAVI Co., a medical device manufacturer in Denver, CO, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included a lack of software validation for distributed EEG systems, inadequate CAPA procedures, and failures in establishing proper procedures for acceptance activities, complaint handling, equipment calibration, and quality audits. The inspection revealed systemic issues in documentation, process validation, and quality control, with some issues being repeat observations.