RIGHTEYE, LLC – FDA 483, Jul 8, 2022

RIGHTEYE, LLC, a medical device manufacturer in Bethesda, MD, was inspected by the FDA, resulting in 10 observations. The inspection revealed significant deficiencies across its quality management system, including failures in design control, management review, quality audits, complaint handling, nonconforming product control, acceptance activities, supplier management, software validation, and employee training. These issues indicate a broad lack of established and followed procedures essential for ensuring device quality and regulatory compliance.