FDA 483 - Padagis US LLC - April 08, 2026

An FDA inspection of Padagis US LLC identified seven significant observations related to manufacturing practices for drug products, dietary supplements, and acidified foods. The firm failed to establish adequate laboratory controls, stability program procedures, and production process controls for drug products. Additionally, issues included inadequate sanitation, incomplete product specifications for dietary supplements, a deficient hazard analysis for human food, and the absence of a scheduled process for acidified foods.