Theragen, IncSeptember 10, 2021

FDA 483 - Theragen, Inc - September 10, 2021

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Record Details

An FDA inspection of Theragen, Inc. in Manassas, VA, a medical device manufacturer, revealed a significant issue regarding document control. The firm was found to be using obsolete labeling specifications for its ActaStim-S Spine Fusion Stimulator device, resulting in finished products being distributed with incorrect labels. This indicates a breakdown in their quality system related to document management and product release.

Company: Theragen, Inc
Inspection Date: September 10, 2021
Product Type: Device
Office: Division of Human and Animal Food Operations - East II
Person: Jude C. Dike

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ID · 4274ada4-a40e-48b9-88cb-5f55acb4efbd