FDA 483 - Orchid Orthopedic Solutions Oregon, Inc. - March 14, 2025

Orchid Orthopedic Solutions Oregon, Inc., a contract manufacturer, received two observations during an FDA inspection. The firm failed to adequately establish procedures for receiving and evaluating complaints, leading to untimely processing of multiple complaint cases. Additionally, the company's training procedures, particularly for on-the-job training, were found to be insufficient, with employees not receiving training from qualified personnel as required.