FDA WARNING_LETTER - Lloyd B. Zimmerman and Sons Farm - October 28, 2010

On October 28, 2010, the FDA inspected Lloyd B. Zimmerman and Sons dairy farm, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale animals for slaughter as food that were adulterated. Specifically, two bob veal calves sold in May and July 2010 contained neomycin residues in kidney tissue (15.14 ppm and 11.51 ppm, respectively), exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves when using the specific medicated milk replacer, thus adulterating the food under 21 U.S.C. 342(a)(2)(C)(ii). The investigation also revealed animals were held under inadequate conditions, making it likely that medicated animals with harmful drug residues would enter the food supply, constituting adulterated food under 21 U.S.C. 342(a)(4). A contributing factor was the failure to maintain complete treatment records. Furthermore, the firm adulterated new animal drugs (oxytetracycline and neomycin in Vigormilk 22BNT Medicated Milk Replacer) by using them extralabel (21 C.F.R. 530.3(a)) without licensed veterinary supervision (21 C.F.R. 530.11(a)), resulting in illegal residues (21 C.F.R. 530.11(c)). This non-conformance rendered the drugs unsafe (21 U.S.C. 360b(a)) and adulterated (21 U.S.C. 351(a)(5)). The FDA requires prompt corrective action, establishment of preventative procedures, and a written response within 15 working days detailing corrections and timelines. Failure to comply may result in regulatory actions such as seizure or injunction.