# FDA 483 - Cognivue Inc. - June 04, 2019

Source: https://www.globalkeysolutions.net/records/483/cognivue-inc/7c8a757b-d354-4501-b3cd-dd37cafba48e

> FDA 483 for Cognivue Inc. on June 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cognivue Inc.
- Inspection Date: 2019-06-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Cognivue Inc., a medical device manufacturer in Victor, NY, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including inadequate software validation, design change procedures, supplier management, CAPA processes, nonconforming product control, device master records, and device history records. These issues indicate a systemic lack of established and followed procedures for critical quality system elements.

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## Related Officers

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

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

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