# FDA 483 - Vasomedical Inc - December 16, 2019

Source: https://www.keypedia.com/records/483/vasomedical-inc/37a9c20c-3116-4b63-885a-880acc398f80

> FDA 483 for Vasomedical Inc on December 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vasomedical Inc
- Inspection Date: 2019-12-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Vasomedical Inc, a medical device manufacturer in Plainview, NY, revealed significant deficiencies in its quality system, specifically concerning complaint handling and corrective and preventive action procedures. The firm failed to adequately review and investigate all complaints, including device failures potentially related to patient issues. Furthermore, the procedures for managing complaints were found to be inadequate, leading to inconsistent and untimely processing, with these issues being repeat observations from a previous inspection.

## Related Documents

- [483 - 2023-01-09](https://www.keypedia.com/records/483/vasomedical-inc/e2ed3fa8-8d43-4800-a1c4-f2589d10a309)

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

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