FDA 483 - Immersivetouch Inc - September 14, 2023

An FDA inspection of Immersivetouch Inc. in Chicago, IL, revealed significant deficiencies in their quality management system. The firm failed to adequately establish design change procedures for their ImmersiveView™Software, a repeat observation, and did not perform required internal quality audits for multiple years. These findings indicate a lack of adherence to established quality system requirements for medical device manufacturing.