483
Oximeter Plus, IncFDA 483 - Oximeter Plus, Inc - July 21, 2023
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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.
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ID · 0eb4f296-7688-4d4b-a84d-839f589d9cb3