FDA WARNING_LETTER - Willie Schmucker - April 17, 2014

An FDA inspection conducted on April 9, 10, and 17, 2014, at Willie Schmucker's livestock operation in Waterloo, New York, revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated veal calf for slaughter, as tissue samples showed sulfadimethoxine residues, which have no acceptable tolerance for veal, violating 21 U.S.C. § 342(a)(2)(C)(ii). Additionally, animals were held under inadequate conditions, such as failing to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). The firm also adulterated the drug (b)(4) (sulfadimethoxine) Soluble Powder through extralabel use. Specifically, the drug was administered to a veal calf without following the approved animal class and to cattle's drinking water without following the approved dosage, both instances occurring without the supervision of a licensed veterinarian, violating 21 C.F.R. § 530.11(a). Furthermore, one instance of extralabel use resulted in an illegal drug residue, violating 21 C.F.R. § 530.11(d). These extralabel uses rendered the drug unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). The FDA requires prompt corrective actions, including establishing procedures to prevent recurrence, with a written response due within fifteen working days detailing steps taken or planned. Failure to comply may lead to regulatory actions like seizure or injunction.