483
Immersivetouch IncFDA 483 - Immersivetouch Inc - September 14, 2023
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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.
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