FDA WARNING_LETTER - Whitestone Feeds LLC - January 25, 2017

The FDA conducted an investigation of Whitestone Feeds LLC's facility from December 20, 2016, to January 25, 2017, following reports of cattle deaths linked to their "(b)(4)" free-choice protein tub. The inspection revealed significant deficiencies, leading to the product being deemed adulterated under section 402(a)(3) of the FD&C Act, as it was unfit for food.

The " (b)(4) " tubs' soft consistency caused overconsumption by cattle, resulting in ammonium toxicity from non-protein nitrogen (NPN) due to feed-grade urea. Necropsies confirmed ammonia toxicosis, and testing found excessive NPN. The firm admitted to shipping inadequately cured tubs and not using metering devices for wet ingredients, along with issues with corn steep liquor quality and ingredient mixing. The introduction of this adulterated food into interstate commerce is a prohibited act under section 301(a) of the FD&C Act.

Additionally, Whitestone Feeds LLC failed to report a reportable food to the Reportable Food Registry (RFR) within 24 hours, as required by section 417(d)(1) of the FD&C Act. Despite being notified of animal deaths and their RFR responsibility, the firm delayed reporting until an FDA investigator intervened. Failure to submit a required RFR is a prohibited act under section 301