FDA WARNING_LETTER - Christopher F. Anderson - August 30, 2013

The FDA conducted an inspection of Kissamee Farms, a dairy operation, on August 27 and 30, 2013, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary findings included the sale of a calf for slaughter with illegal sulfadimethoxine residues in its kidney tissue, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The detected residue exceeded the established tolerance for cattle and had no acceptable level for veal calves, the animal class involved. Furthermore, the farm was found to hold animals under inadequate conditions, such as failing to maintain treatment records, which makes 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 drug (b)(4) (sulfadimethoxine) (b)(4) itself was deemed adulterated because it was used in an extralabel manner, specifically administered to a bob veal calf without following approved labeling. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal drug residues (21 C.F.R. 530.11(d)). Kissamee Farms is required to take prompt corrective action to address these violations and implement procedures to prevent recurrence. A written response detailing these steps, including timelines and documentation, must be submitted to the FDA within fifteen working days. Failure to comply may lead to further regulatory actions, such as seizure or injunction.