483
Immersivetouch IncImmersivetouch Inc – FDA 483, Sep 14, 2023
Record Details
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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- Chicago District Office
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ID · 4fe0b6f6-405c-4171-a603-362e69321867
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