FDA 483 - Five Star Orthodontic Laboratory & Supply, Inc. - March 17, 2025

Five Star Orthodontic Laboratory & Supply, Inc. in Denton, TX, a manufacturer of orthodontic devices, was cited for multiple significant deficiencies in its quality system during an FDA inspection. The observations highlight systemic issues across corrective and preventive actions, device history records, complaint handling, recordkeeping, equipment maintenance, supplier management, and employee training. These findings indicate a broad lack of adherence to established procedures and regulatory requirements, posing a risk to product quality and patient safety.