FDA WARNING_LETTER - Sprague Ranch, LLC - August 27, 2013

On July 26 and August 27, 2013, the FDA inspected Sprague Ranch, LLC, and found violations of the Federal Food, Drug, and Cosmetic Act. The company offered for sale two dairy cows for slaughter as food that were adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), because they contained unsafe new animal drug residues. Specifically, USDA/FSIS analysis of tissue samples from two cows sold on September 18, 2012, and September 10, 2012, revealed desfuroylceftiofur levels of 1.45 ppm and 1.86 ppm in kidney tissue, respectively. This exceeds the FDA tolerance of 0.4 ppm for desfuroylceftiofur in uncooked edible kidney tissue of cattle (21 C.F.R. 556.113(b)(3)).

Furthermore, the FDA found that animals were held under insanitary conditions, rendering food injurious to health, a violation of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4). This was evidenced by the failure to maintain complete treatment records, increasing the likelihood of