FDA WARNING_LETTER - McCormick Family Dairy, LLC - September 30, 2015

On August 21, 24, 25, 31, and September 30, 2015, the FDA investigated McCormick Family Dairy, LLC, finding multiple violations of the Federal Food, Drug, and Cosmetic Act. Two veal calves sold for slaughter were adulterated: one on March 9, 2015, contained 0.11 ppm ampicillin in kidney and 0.06 ppm in muscle (tolerance 0.01 ppm); another on July 27, 2015, contained 2.27 ppm sulfamethazine in muscle and 6.19 ppm in liver (tolerance 0.1 ppm). These levels exceed established tolerances, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The dairy also held animals under insanitary conditions, lacking a system to control drug administration and failing to maintain complete treatment records, leading to adulteration under 21 U.S.C. 342(a)(4). Furthermore, the firm engaged in extralabel use of Polyflex (ampicillin) and Aureo S-700 3.5G Crumbles (chlortetracycline HCL and sulfamethazine) without veterinary supervision and resulting in illegal residues, violating 21 C.F.R. 530.11(