FDA WARNING_LETTER - Lone Star Calf Ranch, LP - January 30, 2012

On January 27, 28, and 30, 2012, the FDA inspected Lone Star Calf Ranch, LP, identifying violations of the Federal Food, Drug, and Cosmetic Act. The operation sold five bob veal calves for slaughter between October 20 and November 22, 2011, which were found to contain unsafe levels of neomycin and sulfamethoxazole residues. USDA/FSIS analysis showed neomycin in kidney tissue exceeding the 21 CFR 556.430 tolerance for cattle (which does not apply to bob veal calves) and sulfamethoxazole in liver and muscle, for which no tolerance exists in veal calves. This adulterated the food under 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the firm adulterated NeoMed 325 (neomycin sulfate) and Sulfamethoxazole and Trimethoprim (SMZ/TMP) Tablets by using them extralabelly without veterinary supervision, not following approved labeling for animal class/species, administering them in feed, and causing illegal residues. These actions violated 21 CFR 530.11(a), (b), and (c), making the drugs unsafe (21 U.S.C. § 360b(a)) and adulterated (21 U.S.C. § 35