FDA 483 - Access Dental Lab, LLC - June 28, 2021

Access Dental Lab, LLC, a manufacturer of SmileDirectClub Clear Aligners, was inspected in Antioch, TN, revealing significant deficiencies across multiple quality system areas. The firm failed to adequately manage medical device reports and customer complaints, conduct proper design validation for impression kits, and perform complete risk analyses. Additionally, issues were noted with acceptance activities and the validation of software used in the quality system, indicating systemic problems in ensuring product quality and patient safety.