FDA WARNING_LETTER - Ka-vern Farms - August 28, 2013

On August 21 and 28, 2013, the FDA inspected Ka-Vern Farms, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of a bob veal calf for slaughter that was adulterated, containing desfuroylceftiofur (a ceftiofur metabolite) at 0.76 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act. Further, the investigation revealed that animals were held under insanitary conditions, such as failing to maintain treatment records and segregate treated animals, making it likely that medicated animals with harmful drug residues could enter the food supply, violating section 402(a)(4). The new animal drug ceftiofur sodium was also found to be adulterated under section 501(a)(5) due to its extralabel use, specifically administering it without following approved labeling or a veterinarian's prescription (21 C.F.R. 530.3(a)). Moreover, ceftiofur is prohibited for extralabel use in cattle (21 C.F.R. 530.41(a)(13)(ii)), and this extralabel use resulted in an illegal residue, violating 21 C.F.R. 530.11(d). Ka-Vern Farms is required to take prompt corrective action within fifteen working days, providing a written response detailing steps taken to correct violations and prevent recurrence. Failure to comply may lead to regulatory actions like seizure or injunction.