FDA WARNING_LETTER - Leroy B. Horst Jr. - January 22, 2015

On January 15 and 22, 2015, the FDA inspected Leroy B. Horst, Junior's dairy operation in Cayuga, New York, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of a dairy cow for slaughter with ampicillin residues (0.26 ppm) in its kidney, exceeding the 0.01 ppm tolerance (21 C.F.R. 556.40), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also revealed that animals were held under insanitary conditions, including incomplete treatment records and expired drugs, making it likely for medicated animals with harmful residues to enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, the firm adulterated new animal drugs, Ampicillin and Tetracycline HCL, through extralabel use not directed by approved labeling or veterinary prescription. Specifically, these drugs were used without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a), and the extralabel use of Ampicillin resulted in illegal residues, violating 21 C.F.R. 530.11(d). The letter also cited the prohibited extralabel use of Cephapirin Benzathine via feed, specifically by feeding colostrum from treated cows to calves, which is prohibited by 21 CFR 530(b). The FDA requires prompt corrective action and establishment of preventative procedures, with a written response due within fifteen working days detailing steps taken or planned, including documentation, to avoid further regulatory action like seizure or injunction.