Steuart Nutrition, Inc. – FDA 483, May 7, 2026

An FDA inspection of Steuart Custom Products, Inc. in Le Roy, MN, a drug manufacturer, revealed significant deficiencies across multiple systems. The firm failed to adequately validate cleaning processes for shared equipment, qualify upgraded manufacturing equipment, and implement proper controls for computer systems to ensure data integrity. Additionally, the environmental monitoring program was found to be insufficient for preventing objectionable microorganisms in non-sterile drug products.