FDA 483 - XRD Dental Equipment - January 31, 2025

An FDA inspection of X Ray Discount Dental Equipment, LLC, an importer in Orlando, FL, revealed significant deficiencies in its quality system. The firm was cited with six observations for failing to establish written procedures for critical processes including complaint handling, Medical Device Reporting (MDR), corrective and preventive actions (CAPA), purchasing, acceptance activities, and control of storage areas. These findings indicate a fundamental absence of a robust quality management system.