FDA 483 - Trinity Medical Devices, Inc. - May 07, 2025

Trinity Medical Devices, Inc. in Morristown, NJ, was cited for inadequate complaint handling procedures during an FDA inspection of its complaint file establishment. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, specifically regarding the investigation of possible device failures. This deficiency was evident in 4 out of 5 reviewed complaints, involving various medical devices such as endotracheal tubes, neonatal electrodes, thermal reflectors, and ventilator circuits.