# FDA 483 - Cognivue Inc. - June 13, 2025

Source: https://www.keypedia.com/records/483/cognivue-inc/d99a1d81-1298-4bf1-89c7-a4c90c96c41f

> FDA 483 for Cognivue Inc. on June 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cognivue Inc.
- Inspection Date: 2025-06-13
- Product Type: device
- Office Name: New York District Office
- Summary: 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.

## Related Documents

- [483 - 2019-06-04](https://www.keypedia.com/records/483/cognivue-inc/7c8a757b-d354-4501-b3cd-dd37cafba48e)
- [483 - 2022-08-15](https://www.keypedia.com/records/483/cognivue-inc/c044f19a-5d29-4179-8ca7-a7601d6cc695)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/cognivue-inc/12d584b2-cd96-4b0f-9d92-6efb90102a80

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d