FDA WARNING_LETTER - Box Canyon Dairy - November 02, 2011

On November 1-2, 2011, the FDA inspected a dairy operation at 1600 East 3490 South, Wendell, Idaho, and found violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on April 30, 2011, and slaughtered on May 4, 2011, contained 0.25 ppm of sulfadimethoxine in liver tissue, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug Di-Methox Injection (sulfadimethoxine) was adulterated because it was used extralabelly without veterinary supervision, violating 21 C.F.R. 530.3(a). Specifically, sulfadimethoxine was administered to a dairy cow without following the approved dose and withdrawal period. Extralabel use of sulfadimethoxine in lactating dairy cattle is prohibited by 21 C.F.R. 530.41(