FDA WARNING_LETTER - Bradley M. Burton - April 17, 2013

On April 15 and 17, 2013, the FDA inspected Bradley M. Burton's dairy operation in Columbia, KY, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of adulterated animals for slaughter. Specifically, two dairy cows sold on October 29 and December 20, 2012, contained desfuroylceftiofur, a ceftiofur metabolite, in kidney tissue at levels of 1.51 ppm and 7.11 ppm, respectively, far exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. § 556.113). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act. Additionally, the investigation revealed that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, rendering food adulterated under section 402(a)(4) of the Act. Deficiencies included failure to maintain treatment records, segregate treated animals, properly identify animals, inquire about medication status of purchased animals, and correctly store and dispose of drugs. Mr. Burton is responsible for ensuring compliance and must take prompt corrective action to address these violations and prevent recurrence. A written response detailing corrective steps, timelines, and supporting documentation is required within fifteen working days. Failure to comply may lead to further regulatory actions, such as seizure or injunction.