# FDA 483 - Koios Medical, Inc. - May 13, 2021

Source: https://www.keypedia.com/records/483/koios-medical-inc/527db7b3-8c0a-4505-9298-0d3f2d1cb700

> FDA 483 for Koios Medical, Inc. on May 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Koios Medical, Inc.
- Inspection Date: 2021-05-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Koios Medical, Inc., a medical software manufacturer in New York, NY, was issued a Form FDA-483 following an inspection. The inspection revealed two observations related to inadequate maintenance of device history records and a failure to maintain written Medical Device Reporting (MDR) procedures, including not registering for the eMDR system.

## Related Officers

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

Company: https://www.keypedia.com/companies/koios-medical-inc/c37a258f-40a4-459a-9540-0b5f6257dde2

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