FDA WARNING_LETTER - Nutra Blend, LLC subsidiary of Land O’Lakes - December 16, 2022

The FDA inspected a medicated feed mill in Mason City, IA, from December 12-16, 2022, following a Reportable Food Registry (RFR) report of calf illnesses and deaths linked to Purina Rangeland Calf Creep 14 B68 Medicated, lot # 101022. Lab analyses confirmed the presence of monensin, an unintended drug, in the feed, leading to a recall on December 7, 2022.

The inspection revealed significant violations: 1. **Current Good Manufacturing Practice (CGMP) for Medicated Feeds (21 CFR Part 225):** The firm failed to properly identify and control drugs in mixing areas (21 CFR 225.42(b)(4)). An operator erroneously added monensin to the calf feed due to removing barcode tags from staged micro-ingredients, leaving them unidentified. The subsequent product, Accuration Finisher 44 R227, was found to be lower in monensin than labeled. The firm's updated SOPs for barcode scanning and staging were noted, but supporting documentation for consistent implementation was requested. 2. **Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507):** The firm failed to sufficiently assess the probability of hazards (21 CFR 507.33(c)(1)).