FDA WARNING_LETTER - John Stewart Horton - September 06, 2012

The FDA conducted an investigation of John Stewart Horton's dairy operation on August 20 and September 6, 2012, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of five bob veal calves for slaughter as food that were adulterated, containing illegal residues of neomycin in their kidney tissues, exceeding the established tolerance of 7.2 ppm (21 C.F.R. 556.430(b)(1)). This constitutes adulterated food under section 402(a)(2)(C)(ii) of the FD&C Act. Further, the investigation revealed that animals were held under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4). Specific deficiencies included failure to maintain treatment records and properly identify bob veal calves for sale. The firm also adulterated the new animal drug (b)(4) (neomycin sulfate and oxytetracycline hydrochloride) through extralabel use, specifically by administering it in or on feed (21 C.F.R. 530.11(b)) and causing illegal drug residues (21 C.F.R. 530.11(c)). This extralabel use, not in conformance with approved labeling, rendered the drug unsafe and adulterated under section 501(a)(5). Additionally, (b)(4) medicated feed was adulterated under section 501(a)(6) due to its use not conforming to approved labeling, making it unsafe under section 512. Mr. Horton is responsible for ensuring compliance and must take prompt corrective action. A written response detailing steps taken to correct violations and prevent recurrence is required within fifteen working days, with potential regulatory actions like seizure or injunction for non-compliance.