Oxus, Inc.September 20, 2013

FDA 483 - Oxus, Inc. - September 20, 2013

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Record Details

An FDA inspection of Oxus America, Inc. in Rochester Hills, MI, revealed a significant issue with device master record maintenance. The firm failed to maintain an approved master specification for primary labels on its Matchbox Oxygen Concentrator medical devices. This indicates a lapse in quality system controls for device labeling.

Company: Oxus, Inc.
Inspection Date: September 20, 2013
Product Type: Device
Office: Division of Pharmaceutical Quality Operations III
Person: Deanna Lampley (investigator)

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