FDA WARNING_LETTER - Hageman Dairy Farms - October 24, 2014

The FDA issued a Warning Letter to North View Dairy following an inspection conducted by the Iowa Department of Agriculture and Land Stewardship on behalf of the FDA in September and October 2014. The inspection of the beef cow-calf, backgrounding, and feeding operation revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm offered for sale two adulterated animals for slaughter. A feeder steer contained neomycin residues (50.52 ppm) significantly above the 7.2 ppm tolerance in kidney tissue. A feeder heifer contained sulfadimethoxine (0.130 ppm) and flunixin (0.147 ppm) residues in liver, exceeding their respective tolerances of 0.1 ppm and 0.125 ppm. These findings render the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). Furthermore, the investigation found animals were held under inadequate conditions, such as a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulteration under 21 U.S.C. 342(a)(4). The firm also adulterated the new animal drug Prevail (flunixin meglumine) by using it extralabel, not as directed by its approved labeling, without licensed veterinary supervision, and resulting in illegal residues, violating 21 C.F.R. Part 530 and rendering the drug unsafe/adulterated. North View Dairy must take prompt corrective action, establish preventative procedures, and respond to the FDA within fifteen working days detailing their compliance plan and any supporting documentation to avoid further regulatory action like seizure or injunction.