# FDA 483 - Eyegaze Inc. - October 08, 2021

Source: https://www.keypedia.com/records/483/eyegaze-inc/c5d96c4b-cdd4-4a42-b0c0-f198f59dfa7b

> FDA 483 for Eyegaze Inc. on October 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eyegaze Inc.
- Inspection Date: 2021-10-08
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Eyegaze Inc., a medical device manufacturer in Fairfax, VA, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for complaint handling, document control, purchasing controls, quality audits, and employee training. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

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## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64