# FDA 483 - Cognivue Inc. - August 15, 2022

Source: https://www.keypedia.com/records/483/cognivue-inc/c044f19a-5d29-4179-8ca7-a7601d6cc695

> FDA 483 for Cognivue Inc. on August 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cognivue Inc.
- Inspection Date: 2022-08-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Cognivue Inc., a medical device manufacturer in Victor, NY, revealed two repeat observations concerning quality system deficiencies. The firm failed to adequately establish procedures for controlling nonconforming products, including proper investigation and identification. Additionally, procedures for device history records were not adequately established, specifically regarding the inclusion of primary identification labels for Cognivue Thrive devices.

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## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961