FDA WARNING_LETTER - Floyd Raber - October 14, 2014

On October 6, 8, and 14, 2014, the FDA inspected Floyd Raber's dairy operation in Millersburg, Ohio, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The inspection revealed that Raber offered for sale an adulterated bob veal calf containing sulfamethoxazole residues, for which no tolerance is established, violating 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, animals were held under inadequate conditions, including a failure to maintain complete treatment records and identify medicated animals, making it likely that animals with harmful drug residues would enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). The firm also adulterated the human drug SMZ/TMP through extralabel use, specifically by not adhering to the veterinarian's prescription and administering it without licensed veterinarian supervision (21 C.F.R. 530.11(a)), which resulted in illegal drug residues (21 C.F.R. 530.11(c)). This extralabel use rendered the drug unsafe and adulterated under 21 U.S.C. §§ 360b(a) and 351(a)(5). Finally, Raber provided a false guaranty regarding drug residues in animals presented for slaughter, a prohibited act under 21 U.S.C. § 331(h). The FDA requires prompt corrective action, including establishing procedures to prevent recurrence, and a written response within fifteen working days detailing these steps and providing documentation, warning of potential regulatory actions like seizure or injunction if non-compliance continues.