# FDA 483 - Aeye Health Inc. - March 15, 2024

Source: https://www.keypedia.com/records/483/aeye-health-inc/5933b382-dad8-4979-a85b-66fe92b65067

> FDA 483 for Aeye Health Inc. on March 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aeye Health Inc.
- Inspection Date: 2024-03-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Aeye Health Inc., a medical device manufacturer in New York, NY, received a Form FDA 483 for failing to maintain written Medical Device Reporting (MDR) procedures. The firm specifically lacked electronic Medical Device Reporting (eMDR) procedures and had not established an Electronic Submissions Gateway (ESG) account. These deficiencies are critical as they prevent the proper handling of reports for serious injuries and deaths related to their medical devices.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/aeye-health-inc/c8a04733-8454-4d3e-9e67-c2aebd528c50

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