Nutra Blend, LLC subsidiary of Land O’Lakes

Warning LetterOpen

Ms. Lisa Deverell President, Purina Animal Nutrition; Executive Vice President, Land O’ Lakes, Inc. Nutra Blend, LLC subsidiary of Land O’Lakes 4001 Lexington Avenue North Arden Hills , MN 55126 United StatesIssued May 22, 2023Division of Human and Animal Food Operations West II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations6

Issue DateMay 22, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Nutra Blend, LLC subsidiary of Land O’Lakes
Location: Ms. Lisa Deverell President, Purina Animal Nutrition; Executive Vice President, Land O’ Lakes, Inc. Nutra Blend, LLC subsidiary of Land O’Lakes 4001 Lexington Avenue North Arden Hills , MN 55126 United States
FEI Number: N/A
Country: United States
Issue Date: May 22, 2023
Issuing Office: Division of Human and Animal Food Operations West II
Product Type: Drugs
Status: Open

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.

Nutra Blend, LLC subsidiary of Land O’Lakes FDA Warning Letter, May 22, 2023