FDA WARNING_LETTER - Erickson Dairy LLC - December 06, 2013

The FDA inspected Erickson Dairy, LLC on December 2, 4, and 6, 2013, uncovering multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm sold an adulterated dairy cow for slaughter on June 13, 2013, which contained desfuroylceftiofur residues at 1.51 ppm (tolerance 0.4 ppm) and flunixin at 1.02 ppm (tolerance 0.125 ppm) in edible tissues, making the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Additionally, the dairy held animals under insanitary conditions, failing to maintain treatment and animal identity records, increasing the risk of drug-adulterated animals entering the food supply, a violation of 21 U.S.C. § 342(a)(4). The firm also adulterated new animal drugs, including ceftiofur, flunixin, and ampicillin, through extralabel use not directed by approved labeling. This included incorrect injection amount/site for ceftiofur, incorrect route of administration for flunixin, and incorrect treatment duration for ampicillin. These extralabel uses were not supervised by a licensed veterinarian (21 C.F.R. 530.11(a)) and, for ceftiofur and flunixin, resulted in illegal drug residues (21 C.F.R. 530.11(d)). These actions rendered the drugs unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). Erickson Dairy must implement corrective actions and respond within 15 working days to avoid further regulatory action.