FDA WARNING_LETTER - Valley View Milling LLC - December 16, 2021

The FDA inspected an animal food manufacturing facility in Seneca, Kansas, from December 7-16, 2021, following complaints and a Kansas Department of Agriculture (KDA) investigation into sheep deaths from copper poisoning. A KDA sample of "Custom Ewe Feed ClariFly" medicated feed showed elevated copper levels (155.6 ppm), significantly exceeding the 15 ppm maximum tolerable level for sheep, rendering the product adulterated and potentially fatal. This led to a voluntary Class 1 recall on December 8, 2021, for this and two other sheep feed products.

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), causing products to be adulterated. Specifically, the facility failed to sufficiently assess hazard probability (21 CFR 507.33(c)(1)). Prerequisite programs for managing copper toxicity and drug carryover were not implemented, with six instances of sheep feed production without proper procedures and one instance of horse feed production following medicated cattle feed without proper procedures, leading to adulterated food. The facility's food safety plan for aflatoxin in corn was also insufficient, relying on inadequate testing and not addressing mycotoxin development during storage, especially for aflatoxin-sensitive animals.

Furthermore, the facility failed to conduct a comprehensive hazard analysis (21 CFR 507