FDA 483 - Portal 724 LLC - June 05, 2025

Portal 724 LLC, a specification developer in Little Falls, NJ, received a Form FDA 483 with four observations during an inspection. The firm failed to adequately establish and implement critical quality system procedures, including complaint handling, medical device reporting (MDR), corrective and preventive actions (CAPA), and purchasing controls. Two of these failures, MDR procedures and CAPA, were noted as recurring observations, indicating persistent issues with their quality system.