LeCaptain, Mark D. – FDA Warning Letter, Sep 27, 2011

An FDA investigation conducted on September 22 and 27, 2011, at Mark D. LeCaptain's dairy operation in Casco, Wisconsin, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated bob veal calf for slaughter, which contained illegal residues of tilmicosin (13.728 ppm in liver) and sulfamethazine (10.170 ppm in liver, 8.161 ppm in muscle), exceeding established tolerances or having no acceptable level for veal calves, thus violating 21 U.S.C. § 342(a)(2)(C)(ii). Additionally, animals were held under insanitary conditions, specifically due to a failure to maintain complete treatment records, increasing the likelihood of medicated animals with harmful residues entering the food supply, a violation of 21 U.S.C. § 342(a)(4). The new animal drugs (b)(4) (tilmicosin injection) and (b)(4) (sulfamethazine) were also found to be adulterated because they were used in an extralabel manner, not as directed by approved labeling or a servicing veterinarian's prescription, and without licensed veterinary supervision, violating 21 CFR 530.11(a) and (c). The FDA requires prompt corrective action, including establishing procedures to prevent recurrence. A written response detailing corrective steps and timelines must be submitted within 15 working days to avoid further regulatory action like seizure or injunction.