FDA WARNING_LETTER - Dorsey Farms, Inc. - January 26, 2012

An FDA inspection conducted on January 24 and 26, 2012, at a dairy operation in Caldwell, Idaho, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated animal for slaughter; specifically, a dairy cow consigned for food had 0.1 ppm of penicillin in its kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, the firm held animals under insanitary conditions, such as failing to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, which constitutes adulteration under 21 U.S.C. § 342(a)(4). The firm also adulterated the new animal drug penicillin through extralabel use, administering it without following approved labeling, without licensed veterinarian supervision (21 C.F.R. 530.11(a)), and resulting in illegal drug residues (21 C.F.R. 530.11(d)). This rendered the drug unsafe and adulterated (21 U.S.C. § 360b(a), 21 U.S.C. § 351(a)(5)). Additionally, the firm provided a false Ruminant-derived Protein/Drug Residue Certificate, a prohibited act under 21 U.S.C. § 331(h). The firm's written response dated February 3, 2012, was deemed inadequate as it failed to detail how drug label directions would be followed, how future violations would be prevented, or provide sufficient information on their drug inventory system. The FDA requires prompt corrective action within fifteen working days, including documentation, to prevent recurrence, or face potential regulatory action.