FDA 483 - Lattice Inc - May 22, 2025

Lattice Inc, a software manufacturer in Wheaton, IL, was cited for seven significant quality system deficiencies during an FDA inspection. Key issues include inadequate risk analysis for its MediCopia Transfusion device, deficiencies in corrective and preventive action procedures, and a lack of proper unique device identification (UDI) on device labels. Several observations were repeats from previous inspections, indicating persistent non-compliance.