Suther Feeds, Inc. Warning Letter Details

Summary

Suther Feeds, Inc. manufactured and distributed a medicated cattle feed containing an unsafe, super-potent concentration of monensin (exceeding the labeled 20 grams/ton dosage), resulting in cattle deaths that triggered a Class I recall in January 2023. The company violated Current Good Manufacturing Practice (CGMP) requirements for medicated feeds under 21 CFR Part 225 and CGMP/Hazard Analysis requirements under 21 CFR Part 507, causing the animal feed to be adulterated. The violations were identified during an FDA inspection in January 2023 that was conducted as a follow-up to a Reportable Food Registry report of suspected monensin poisoning.