FDA 483 - TruAbutment Inc. - January 21, 2025

An FDA inspection of TruAbutment Inc. in Irvine, CA, a manufacturer of Class I and Class II dental implants and accessories, revealed significant deficiencies across its quality management system. Observations included inadequate procedures for design validation, field corrections, process validation, corrective and preventive actions, complaint handling, and document control. The firm also lacked proper unique device identification (UDI) labeling and database submission, and failed to establish device history record procedures.