FDA 483 - Lattice Inc - May 22, 2025

Lattice Inc, a software manufacturer in Wheaton, IL, was inspected and received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies across its quality system, including inadequate risk analysis, unestablished CAPA and labeling procedures, and issues with quality audits, document control, and purchasing controls. Additionally, the firm failed to implement Unique Device Identifiers (UDI) for its medical devices.