FDA 483 - Rapid Reboot Recovery Products, LLC - September 08, 2022

An FDA inspection of Rapid Reboot Recovery Products, LLC in Lindon, UT, a manufacturer of Regen devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design changes, control nonconforming products, and maintain device history records. Additionally, issues were noted with supplier quality agreements, complaint file maintenance, and corrective and preventive action documentation.