FDA 483 - Theragen, Inc - May 23, 2019

Theragen, Inc. in Manassas, VA, a medical device specification developer, was cited for significant deficiencies during an FDA inspection. The firm lacked adequate procedures for medical device reporting, failed to provide sufficient documentation and rationale for design changes, and did not properly control non-conforming products. These observations indicate a need for improved quality system controls for their medical devices, such as the Kneehab XP controller.