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

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.