# FDA 483 - Vasomedical Inc - January 09, 2023

Source: https://www.keypedia.com/records/483/vasomedical-inc/e2ed3fa8-8d43-4800-a1c4-f2589d10a309

> FDA 483 for Vasomedical Inc on January 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vasomedical Inc
- Inspection Date: 2023-01-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Vasomedical Inc in Plainview, NY, from January 4-9, 2023, revealed a significant quality system deficiency. The firm failed to formally appoint a management representative responsible for ensuring quality system requirements are met and reporting on its performance. This indicates a lack of documented oversight in a critical area of quality management.

## Related Documents

- [483 - 2019-12-16](https://www.keypedia.com/records/483/vasomedical-inc/37a9c20c-3116-4b63-885a-880acc398f80)

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/vasomedical-inc/78a19266-23ee-44b4-9816-639e479f50e0

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