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

An FDA inspection of Sun Dental Laboratories, LLC in Saint Petersburg, FL, a manufacturer of dental devices, identified three significant quality system deficiencies. The firm lacked written Medical Device Reporting procedures, failed to establish quality agreements with suppliers for product change notifications, and did not ensure proper examination of labeling for accuracy, specifically regarding Unique Device Identifier (UDI) information for SunClear Aligners.