FDA 483 - Portal 724 LLC - September 21, 2023

Portal 724 LLC in Secaucus, NJ, was cited for significant deficiencies in its quality system, particularly concerning complaint handling, Medical Device Reporting (MDR), and design controls. The inspection revealed a failure to establish and implement critical procedures, leading to unfiled MDRs for serious injuries and a patient death associated with their medical devices. These issues indicate a severe lack of control over product quality and patient safety.