FDA 483 - Ohlendorf Company - June 26, 2024

Ohlendorf Company, a manufacturer of Class II medical devices (Clear Aligners), was cited for significant deficiencies in its quality system. The inspection revealed inadequate organizational structure and a failure to implement essential Quality System Regulation requirements, including design, complaint, CAPA, process, and management controls. Additionally, the firm failed to apply Unique Device Identifier (UDI) labeling to its medical devices and did not submit required device information to the Global Unique Device Identification Database (GUDID).