Hillegass Dairy, LLC. – FDA Warning Letter, Oct 31, 2013

The FDA issued a Warning Letter to Hillegass Dairy, LLC following an October 23-31, 2013, investigation, citing multiple Federal Food, Drug, and Cosmetic Act violations. The firm sold adulterated animals for slaughter. Two dairy cows had ceftiofur residues (3.25 ppm and 2.07 ppm in kidney) exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113). Two bob veal calves contained tulathromycin and ceftiofur residues, for which no acceptable levels exist in bob veal calves. These findings render the food adulterated under section 402(a)(2)(C)(ii). The investigation also found animals held under inadequate conditions, including poor treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4). Furthermore, the firm adulterated new animal drugs, Excenel RTU (ceftiofur) and Draxxin (tulathromycin), through extralabel use not directed by approved labeling (21 C.F.R. 530.3(a)). This extralabel use lacked licensed veterinarian supervision (21 C.F.R. 530.11(a)), and Excenel RTU is prohibited for extralabel use in food-producing animals (21 C.F.R. 530.41(13)(iii)), leading to illegal drug residues (21 C.F.R. 530.11(c)). These actions caused the drugs to be unsafe and adulterated (FD&C Act 512(a), 501(a)(5)). Hillegass Dairy must promptly correct violations and respond within 15 working days, detailing corrective and preventive measures, or face potential regulatory action.