FDA WARNING_LETTER - Jerry Slabaugh - July 03, 2014

An FDA investigation in June and July 2014 at Jerry Slabaugh's dairy operation in Kenton, Ohio, identified multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm sold an adulterated bob veal calf for slaughter, containing sulfamethazine residues (0.123 ppm) exceeding the 0.10 ppm tolerance (21 C.F.R. 556.670) and tulathromycin, for which no tolerance exists in bob veal calves, violating 21 U.S.C. § 342(a)(2)(C)(ii). Animals were also held under inadequate conditions, including poor record-keeping, increasing the risk of drug-adulterated food entering the supply, a violation of 21 U.S.C. § 342(a)(4).

The firm further adulterated new animal drugs Draxxin and Aureo S 700 2G Crumbles through extralabel use. Draxxin was used off-label, without licensed veterinarian supervision (21 C.F.R. 530.11(a)), and resulted in illegal drug residues (21 C.F.R. 530.11(c)), rendering the drug unsafe and adulterated (21 U.S.C. §§ 360b(a), 351(a)(5)). Similarly, Aureo S 700 2G Crumbles was used extralabelly, without veterinary supervision (21 C.F.R. 530.11(a)), and caused illegal drug residues (21 C.F.R. 530.11(d)), leading to its adulteration (21 U.S.C. §§ 360b(a), 351(a)(6)). The letter emphasized that extralabel use of medicated feed is prohibited (21 U.S.C. § 360b, 21 C.F.R. § 530.11(b)).

Mr. Slabaugh must promptly correct all violations, establish preventive procedures, and respond to the FDA within 15 working days with detailed corrective actions and documentation. Non-compliance may lead to regulatory actions such as seizure or injunction.