FDA 483 - Lattice Inc - January 17, 2020

Lattice Inc., a medical software device firm in Wheaton, IL, received a Form 483 with five observations primarily concerning inadequate quality system procedures. The firm failed to establish proper procedures for complaint investigations, design changes, corrective and preventive actions, complaint file maintenance, and control of non-conforming products, indicating significant deficiencies in its quality management system. These issues impact the safety and efficacy of its Medicopia software, particularly concerning blood/tissue transfusion verification.