FDA 483 - Lujena, Inc - November 19, 2024

Lujena, Inc. in El Cajon, CA, a manufacturer of Class 2 medical devices, was inspected by the FDA from November 12-19, 2024. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures and documentation for design risk analysis, device history records, supplier management, complaint handling, UDI registration, management review, and quality audits. Many critical procedures were only established immediately prior to or during the inspection, and historical records were largely absent.