FDA 483 - All Ways Dental, LLC. - February 26, 2020

All Ways Dental, LLC. in Apache Junction, AZ was inspected by the FDA on February 26, 2020. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the lack of established procedures for corrective and preventive actions, medical device reporting, and complaint handling for unclassified dental restorations. These issues indicate a fundamental lack of controls necessary to ensure product quality and safety.