483
Cognivue Inc.FDA 483 - Cognivue Inc. - June 13, 2025
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An FDA inspection of Cognivue Inc., a medical device manufacturer in Victor, NY, revealed two significant observations. The firm failed to maintain adequate documentation for complaint investigations and did not designate an active point of contact with the FDA for medical device identification in the GUDID system.
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ID · d99a1d81-1298-4bf1-89c7-a4c90c96c41f