FDA WARNING_LETTER - Hi-Pro Feeds, LLC - August 04, 2023

The FDA issued a Warning Letter to Hi-Pro Feeds, LLC following an inspection from July 31 to August 4, 2023, initiated by a Reportable Food Registry (RFR) report. The inspection revealed significant violations of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), rendering products adulterated.

The violations stem from a medicated goat feed, Windy Acres Show Ration (lot 0015932234), manufactured on April 19, 2023, which caused illnesses and deaths in a customer's goat herd due to elevated urea levels. The company's third-party lab confirmed urea presence, and necropsy reports indicated toxicity. A recall was initiated on July 7, 2023.

Specific violations include: 1. **Failure to conduct a proper hazard analysis (21 CFR 507.33(a))**: The company's hazard analysis did not identify nutrient toxicity from excess urea as a known or reasonably foreseeable chemical hazard, particularly regarding urea carryover at various production steps like the distributor head or receiving. The updated Animal Food Safety Plan was deemed insufficient as it only addressed urea at one step and lacked supporting documentation for a comprehensive evaluation. 2. **Failure to report a reportable food to the RFR within 24 hours (Section 4