# FDA 483 - Oximeter Plus, Inc - February 20, 2020

Source: https://www.keypedia.com/records/483/oximeter-plus-inc/f2943f93-7c39-4c1e-91f9-45941599a455

> FDA 483 for Oximeter Plus, Inc on February 20, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oximeter Plus, Inc
- Inspection Date: 2020-02-20
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Oximeter Plus, Inc. in Roslyn Heights, NY, an importer, was inspected by the FDA from February 19-20, 2020. The inspection revealed deficiencies in establishing and assessing supplier requirements, including a lack of vendor compliance assessments despite procedures referencing 21 CFR 820. Additionally, the firm failed to adequately control non-conforming products, lacking records to track them despite having a procedure for notification.

## Related Documents

- [483 - 2023-07-21](https://www.keypedia.com/records/483/oximeter-plus-inc/0eb4f296-7688-4d4b-a84d-839f589d9cb3)

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

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