FDA 483 - Rebuilder Medical, Inc. - November 29, 2022

An FDA inspection of Rebuilder Medical, Inc. in Charles Town, WV, a manufacturer of medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately investigate device complaints, validate embedded software for its ReBuilder models, and document corrective and preventive actions. Additionally, the inspection found issues with risk analysis for device accessories, incomplete device master records, and an inadequate organizational structure lacking quality and regulatory oversight.