FDA 483 - Immersivetouch Inc - January 29, 2020

ImmersiveTouch Inc. in Chicago, IL, a device manufacturing firm, was inspected by the FDA from January 23-29, 2020. The inspection revealed significant deficiencies in the design control processes for their ImmersiveView® software, a Class II device. Specifically, the firm failed to perform design validation and verification, adequately review and approve design inputs and outputs, and establish proper procedures for design changes.