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Purina Animal Nutrition LLC's Gonzales, Texas facility manufactured animal feed products containing elevated urea levels that posed serious health risks and death to ruminant animals, leading to a Class I recall of four products in October 2021. FDA investigators found significant violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls requirements under 21 CFR Part 507, rendering the products adulterated. The inspection was conducted as a follow-up to the urea contamination recall, and the company had not responded to the FDA 483 observations issued at the close of inspection.