FDA 483 - Portal 724 LLC - June 05, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 5fbb51f2-adc6-482e-bb14-63d1917cdf40