Lattice IncMay 22, 2025

FDA 483 - Lattice Inc - May 22, 2025

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Record Details

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.

Company: Lattice Inc
Inspection Date: May 22, 2025
Product Type: Device
Office: FDA District Office — Chicago, Illinois
People: Lesley Mae P. Lutao
Zoey A. Trombley (FDA_PERSONNEL)

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ID · 32200d24-cd21-427c-849b-d4ec520552f9