FDA WARNING_LETTER - Vander Hoff Bros. Dairy, L.L.C. - April 13, 2015

On March 18, April 8, and April 13, 2015, the FDA inspected Vander Hoff Bros. Dairy, LLC, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale a dairy cow for slaughter that was adulterated, containing desfuroylceftiofur and flunixin residues exceeding established tolerances (21 U.S.C. § 342(a)(2)(C)(ii)). Additionally, the firm held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply (21 U.S.C. § 342(a)(4)). The FDA also found that the firm adulterated the new animal drug VetaMeg through extralabel use, administering it without following approved labeling for route and withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal drug residues (21 C.F.R. 530.11(d)), rendering the drug unsafe and adulterated (21 U.S.C. § 360b(a), 21 U.S.C. § 351(a)(5)). Furthermore, the firm provided a false Livestock Owner Certificate, a prohibited act under 21 U.S.C. § 331(h). The FDA requires prompt corrective action, establishment of preventative procedures, and a written response within fifteen working days detailing steps taken or planned, with documentation. Failure to comply may result in regulatory actions such as seizure or injunction.