FDA WARNING_LETTER - Roach's Dairy Farm - September 30, 2014

On September 24 and 30, 2014, the FDA inspected Roach's Dairy Farm, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on April 17, 2014, was found to have desfuroylceftiofur (ceftiofur marker residue) at 1.94 ppm in kidney tissue, exceeding the 0.4 ppm tolerance for cattle and having no acceptable level for veal calves. This rendered the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including failure to maintain complete treatment records, failure to identify animals transported for sale, and holding expired drugs. These conditions suggest medicated animals with harmful residues could enter the food supply, adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the farm engaged in extralabel drug use without veterinary supervision, violating 21 C.F.R. Part 530. Specifically, (b)(4) was routinely administered to pre-ruminating calves, which is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(iii). Additionally, (b)(4) was administered to cows without