FDA 483 - Sun Dental Laboratories, LLC - September 20, 2023

An FDA inspection of Sun Dental Laboratories, LLC in Saint Petersburg, FL, revealed significant deficiencies in their quality system. The firm lacked written Medical Device Reporting procedures, failed to establish quality agreements with suppliers for their SunClear Aligners, and did not adequately examine labeling for required Unique Device Identifier (UDI) information. These observations indicate a need for improved quality control and regulatory compliance.