FDA WARNING_LETTER - Roth, Lonny M. - May 31, 2013

On May 29 and 31, 2013, the FDA inspected Lonny M. Roth's dairy farm in Cadott, Wisconsin, revealing significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation found that Mr. Roth offered for sale animals for slaughter as food that were adulterated, specifically dairy heifers and cows containing illegal residues of penicillin, sulfadimethoxine, and flunixin above established tolerances (21 CFR 556.510, 556.640, 556.286), violating 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, animals were held under inadequate conditions, such as a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues would enter the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4). The firm also adulterated the new animal drug penicillin through extralabel use, administering it without following approved labeling for dose, frequency, and injection site. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 CFR 530.11(a), rendering the drug unsafe and adulterated (21 U.S.C. § 351(a)(5)). Mr. Roth is required to take prompt corrective action, establish preventative procedures, and respond to the FDA within 15 working days, detailing steps taken. Failure to comply may lead to regulatory actions like seizure or injunction.