battle creek co-op/chs, llc – FDA Warning Letter, Feb 15, 2023

On August 14, 2023, the FDA issued a Warning Letter to Battle Creek/CHS LLC dba Progressive Nutrition following a January 2023 inspection by the Nebraska Department of Agriculture. The inspection was prompted by a Reportable Food Registry report concerning cattle deaths linked to "PN 16-8-12 Mineral R-1G" lot # M217160, which contained excessive urea. This led to a voluntary recall expanded to include lot # M217170.

The inspection revealed significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), and Current Good Manufacturing Practice for Medicated Feeds (21 CFR Part 225), rendering products adulterated.

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR 507.33(a)):** Failure to identify nutrient toxicity (urea) and mycotoxins (DON, fumonisin, aflatoxin) as known or reasonably foreseeable hazards. The firm's revised hazard analysis was deemed insufficient, lacking full evaluation of urea carryover and specific details on mycotoxin testing procedures. 2. **CGMP - Facility Maintenance (21 CFR 507.19(a)):** Bulk storage bins were not kept clean and in good repair, leading to cross-contamination (urea