Nutra Blend, LLC subsidiary of Land O’Lakes Warning Letter Details

Summary

Nutra Blend, LLC, a Land O'Lakes subsidiary operating a medicated feed mill, manufactured Purina Rangeland Calf Creep 14 B68 Medicated feed contaminated with an unintended drug ingredient (monensin ionophore) that caused calf illnesses and deaths, triggering a recall in December 2022. The FDA inspection found significant violations of Current Good Manufacturing Practice (CGMP) requirements for medicated feeds under 21 CFR Part 225 and CGMP/Hazard Analysis/Risk-Based Preventive Controls for animal food under 21 CFR Part 507, resulting in adulterated product. The contamination was confirmed through the company's own lab analysis, veterinary statements, and necropsy reports showing ionophore toxicity as the cause of death.