FDA WARNING_LETTER - Livestock Nutrition Center - August 23, 2022

On December 15, 2022, the FDA issued a Warning Letter to Livestock Nutrition Center, LLC, following an inspection from August 18-23, 2022, at their Gonzales, TX, animal food manufacturing facility. The inspection was prompted by a Reportable Food Registry (RFR) report filed by the firm after a consumer complaint of multiple illnesses and deaths in a fallow deer herd. The deer consumed "HUGHESDEER16CPv3," a non-medicated deer feed, which third-party lab analysis and retention samples confirmed contained monensin sodium, a medicated feed ingredient toxic to deer.

The FDA found significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), rendering products adulterated. Specifically, the firm failed to conduct a proper hazard analysis, not identifying cross-contamination risks from drugs like monensin at the receiving step. An incident on (b)(4) involved monensin-containing pellets being unloaded into a non-medicated ingredient tank, leading to the contaminated deer feed and subsequent recall. The firm's corrective actions, including changing to bagged medicated ingredients and a "Medicated Reconciliation Plan," were deemed inadequate due to a lack of updated hazard analysis and implementation documentation.

Additionally, the firm failed to identify and evaluate known hazards of fumonisin and deoxynivalenol (DON