FDA WARNING_LETTER - Hugh A Byron - February 15, 2011

On February 14 and 15, 2011, the FDA inspected Hugh A. Byron's dairy operation in Hillsboro, Kentucky, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The inspection revealed three primary issues. First, an animal offered for slaughter was adulterated, containing detectable levels of gentamicin (no established tolerance) and desfuroylceftiofur (5.61 ppm, exceeding the 0.4 ppm tolerance) in its kidney tissue, violating 21 U.S.C. § 342(a)(2)(C)(ii). Second, the firm held animals under inadequate conditions, such as failing to maintain treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under 21 U.S.C. § 342(a)(4). Third, the new animal drug ceftiofur (Excede Sterile Suspension) was adulterated due to extralabel use not directed by approved labeling. Specifically, ceftiofur was administered without following the pre-slaughter withdrawal period and without the supervision of a licensed veterinarian, violating 21 C.F.R. § 530.11(a) and (d), and resulting in illegal drug residues. These actions rendered the drug unsafe and adulterated per 21 U.S.C. § 360b(a) and § 351(a)(5). The FDA requires prompt corrective action, including establishing procedures to prevent recurrence. A written response detailing corrective steps and timelines must be submitted within fifteen working days to avoid further regulatory action like seizure or injunction.