Orthodent Laboratory, Inc. – FDA 483, Nov 13, 2023

Orthodent Laboratory, Inc. was inspected as a medical device manufacturer and received nine observations related to significant quality system deficiencies. The inspection revealed inadequate procedures for corrective and preventive actions, issues with Unique Device Identifier (UDI) labeling and database submission for Vivid Aligners, and insufficient process controls for manufacturing. Additionally, the firm failed to adequately document supplier monitoring, incoming product acceptance, software validation, device history records, and personnel training.