483
Theragen, IncTheragen, Inc – FDA 483, Sep 10, 2021
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.
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ID · 4274ada4-a40e-48b9-88cb-5f55acb4efbd
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