Wenzel Spine, Inc.

FDA 483 - Wenzel Spine, Inc.

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Record Details

An FDA inspection of Wenzel Spine, Inc. in Austin, TX, a device manufacturer, revealed a significant lapse in their quality system. The firm failed to perform and document quality audits for 2023 and 2024, contrary to their own internal procedures. This indicates a potential weakness in their overall quality management system.

Company: Wenzel Spine, Inc.
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Amber Smith

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ID · f842af5c-a859-4117-9c55-63c64b4056b8