Andrew Kiraly – FDA Warning Letter, Aug 29, 2013

The FDA conducted an investigation of Mr. Andrew L. Kiraly's dairy farm in Walton, New York, on August 20, 22, 27, and 29, 2013, revealing multiple violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on January 9, 2013, was found to contain sulfamethazine residues significantly exceeding the 0.1 ppm tolerance in liver (18.47 ppm) and muscle (13.97 ppm), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The farm also held animals under insanitary conditions, including a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, the new animal drug sulfamethazine was adulterated due to extralabel use not directed by its approved labeling. This included administering the drug to a bob veal calf without following the approved animal class, without licensed veterinary supervision (violating 21 C.F.R. 530.11(a)), and resulting in illegal residues (violating 21 C.F.R. 530.11(c)). This extralabel use caused the drug to be unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). Mr. Kiraly must take prompt action to correct these violations and establish preventative procedures. A written response detailing corrective actions and timelines is required within fifteen working days to avoid potential regulatory actions such as seizure or injunction.