FDA 483 - VirtuSense Technologies, Inc. - September 18, 2025

VirtuSense Technologies, Inc. in Peoria, IL, was inspected by the FDA, revealing significant deficiencies in their quality system for manufacturing the Class II medical device, VST Balance. The inspection identified a pervasive lack of established and adequately implemented procedures across critical areas such as personnel training, complaint handling, CAPA, document control, quality policy, quality planning, quality audits, and management review. These findings indicate a fundamental breakdown in the firm's adherence to regulatory requirements for medical device manufacturing.