FDA 483 - Theragen, Inc - September 10, 2021

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.