FDA WARNING_LETTER - Myron J. Diller Farm - August 26, 2010

On August 25-26, 2010, the FDA inspected Myron J. Diller Farm, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was offering an adulterated bob veal calf for slaughter, which contained illegal residues of Neomycin (16.36 ppm in kidney vs. 7.2 ppm tolerance) and Sulfadimethoxine (1.511 ppm in liver, 1.21 ppm in muscle vs. 0.1 ppm tolerance), violating 21 U.S.C. § 342(a)(2)(C)(ii). These tolerances do not apply to veal calves for these drugs. The farm also held animals under inadequate conditions, likely leading to medicated animals with harmful residues entering the food supply, specifically failing to maintain treatment records, violating 21 U.S.C. § 342(a)(4). Furthermore, the new animal drugs Neomycin 200 and Albon Bolus were adulterated due to extralabel use on a bob veal calf without veterinary supervision and resulting in illegal residues, contrary to 21 C.F.R. § 530.11(a) and (c), and 21 U.S.C. § 351(a)(5). Lastly, the animal feed (milk replacer) was adulterated by adding neomycin and not using it according to approved labeling, violating 21 U.S.C. § 351(a)(6) and 21 C.F.R. 530.11(b). The FDA requires prompt corrective actions, including establishing preventative procedures, with a written response due within 15 working days detailing steps taken or planned. Failure to comply may result in regulatory actions like seizure or injunction.