FDA WARNING_LETTER - Suther Feeds, Inc. - January 30, 2023

On August 21, 2023, the FDA issued a Warning Letter to Dr. Johll following an inspection of their animal food manufacturing facility in Clay Center, Kansas, from January 24-30, 2023. This inspection was prompted by a Reportable Food Registry report concerning suspected monensin poisoning from a medicated feed, which led to numerous cattle deaths.

Analysis of a collected medicated cattle feed sample, labeled “(b)(4),” revealed a super potent monensin concentration of (b)(4) grams/ton, significantly exceeding the labeled 20 grams/ton. This led to a voluntary Class I recall initiated on January 10, 2023.

The FDA identified significant violations: 1. **Adulterated Medicated Feed:** The Type C medicated cattle feed containing the Type A medicated article of monensin was deemed unsafe and adulterated because the new animal drug was not used in conformance with its approval (21 U.S.C. § 360b(a)(2)(A) and 21 U.S.C. § 351(a)(6)). 2. **CGMP for Medicated Feeds Violations (21 CFR Part 225):** * Failure to properly identify, handle, and control drugs (21 CFR 225.42(b)(4)).