Fairview Mills, LLC – FDA Warning Letter, Apr 22, 2022

The FDA issued a Warning Letter to an animal food manufacturing facility in Seneca, Kansas, following an inspection from April 11-22, 2022. This inspection was a follow-up to November and December 2021 Kansas Department of Agriculture (KDA) inspections prompted by consumer complaints of suspected copper poisoning in sheep, resulting in multiple deaths. A KDA sample of "Lamb Builder 16% Lamb Creep 80869" collected on November 19, 2021, showed an elevated copper level of 31.0 ppm, exceeding the 15 ppm maximum tolerable level for sheep, causing the product to be adulterated and potentially fatal. The firm initiated a Class I recall on November 19, 2021.

The FDA inspection revealed significant violations of the Hazard Analysis and Risk-Based Preventive Controls for Food for Animals requirements (21 CFR Part 507), rendering products adulterated. Specifically, the facility failed to sufficiently assess the probability of hazards without preventive controls (21 CFR 507.33(c)(1)). Their reliance on prerequisite programs for copper toxicity was ineffective, as evidenced by the recalled product and six instances of non-compliance with their own procedures. The firm's May 12 and June 8, 2022, responses provided blank templates, making corrective actions unverifiable.

Additionally, the firm failed to