FDA WARNING_LETTER - CHS Inc./CHS River Plains - June 23, 2022

On November 30, 2022, the FDA issued a Warning Letter to CHS River Plains following a June 2022 inspection of their Strasburg, North Dakota facility. The inspection revealed significant violations of regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), requirements for Veterinary Feed Directive (VFD) drugs (21 CFR 558.6), and CGMP for Medicated Feeds (21 CFR Part 225). These violations cause products to be adulterated and/or misbranded.

Key violations include: 1. **Hazard Analysis:** Failure to conduct a hazard analysis for known or reasonably foreseeable hazards like fumonisin and deoxynivalenol (DON) in susceptible grains (e.g., corn, oats), and to evaluate their severity and probability. The submitted food safety plan was inadequate as it did not evaluate fumonisin and DON, and lacked methodology for aflatoxin testing. 2. **VFD Requirements and Labeling:** Distribution of VFD feed (Aureomycin 10g crumbles) with unauthorized refills, violating 21 CFR 558.6(c)(2) and specific VFD terms. Invoices, used as labeling, lacked required drug labeling elements (e.g., indication, frequency, duration of use), causing the drug to be misbranded