FDA 483 - Efunctional LLC - March 07, 2024

Efunctional LLC, a medical device manufacturer in Davie, FL, was inspected by the FDA from March 5-7, 2024. The inspection revealed significant deficiencies across its quality system, indicating a lack of established procedures for critical functions such as complaint handling, non-conformance control, CAPA, device history records, supplier management, training, quality audits, and management review. These findings suggest a foundational absence of a robust quality management system.