# FDA 483 - Eyegaze Inc. - May 02, 2025

Source: https://www.keypedia.com/records/483/eyegaze-inc/c20e2f75-080f-4283-8d4d-d7fe47a6e62f

> FDA 483 for Eyegaze Inc. on May 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eyegaze Inc.
- Inspection Date: 2025-05-02
- Product Type: device
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Eyegaze Inc. in Fairfax, VA, a medical device manufacturer, revealed significant deficiencies in quality system procedures. The firm was cited for inadequate control of nonconforming products, improper Unique Device Identifier (UDI) labeling on its medical devices, and a complete lack of procedures for controlling labeling activities. These issues indicate a need for comprehensive improvements in their quality management system.

## Related Documents

- [483 - 2021-10-08](https://www.keypedia.com/records/483/eyegaze-inc/c5d96c4b-cdd4-4a42-b0c0-f198f59dfa7b)

## Related Officers

- [Heath A. Gerber](https://www.keypedia.com/people/heath-a-gerber/3c47dcdd-875c-4f3c-8165-839354a53d8b)

Company: https://www.keypedia.com/companies/eyegaze-inc/b7226d9c-3955-4414-9eaa-53fe6e780b31

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa