# FDA 483 - Oximeter Plus, Inc - July 21, 2023

Source: https://www.keypedia.com/records/483/oximeter-plus-inc/0eb4f296-7688-4d4b-a84d-839f589d9cb3

> FDA 483 for Oximeter Plus, Inc on July 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oximeter Plus, Inc
- Inspection Date: 2023-07-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Oximeter Plus, Inc. in Roslyn Heights, NY, an initial importer and distributor, revealed a significant quality system deficiency. The firm failed to establish adequate procedures for controlling non-conforming products and documenting receiving inspections. Specifically, the company did not document receiving inspections for incoming oximeters.

## Related Documents

- [483 - 2020-02-20](https://www.keypedia.com/records/483/oximeter-plus-inc/f2943f93-7c39-4c1e-91f9-45941599a455)

## Related Officers

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

Company: https://www.keypedia.com/companies/oximeter-plus-inc/c6e206c4-5e68-4175-a92e-74e69a4fca5a

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