FDA WARNING_LETTER - Purina Animal Nutrition LLC - November 10, 2021

The FDA inspected Rick C. Duncan's animal food manufacturing facility in Gonzales, TX, from November 1-10, 2021, following a Class I recall of four Purina animal food products (Antler Advantage Wildlife 16 ARS, 4-Square Breeder 20, Precon Cattle Starter, and 4-Square Stocker/Grower 14) due to elevated urea levels, which can be fatal to ruminants.

The inspection revealed significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements (21 CFR Part 507), rendering products adulterated. The firm failed to sufficiently assess the probability of urea hazards (21 CFR 507.33(c)(1)), as evidenced by urea being mistakenly added to a reprocessed material bin and subsequent recall. Precautions against contamination were inadequate (21 CFR 507.25(a)(5)), with urea unloaded into the wrong pit and diverted to the re-processed materials bin, which was then used in animal food. Adulterated food was not rejected or treated (21 CFR 507.25(a)(7)), as recalled Precon Cattle Starter was sold after the recall.

The FDA also noted the firm's hazard assessment did not list NPN toxicities as high severity, despite the recall. The firm also failed to promptly notify a