FDA 483 - Caldic USA - January 22, 2026

An FDA inspection of Caldic USA in Elgin, IL, conducted on January 21-22, 2026, identified a significant risk of food product contamination. The firm failed to maintain conditions necessary to minimize contamination, specifically observing overspray from a tote washing operation falling into an adjacent production area with exposed food product. This practice creates a potential for contamination of ready-to-use food.