Lin-Ro Farms – FDA Warning Letter, Jul 26, 2012

On July 20, 23, and 26, 2012, the FDA investigated Lin-Ro Farms, a dairy operation, and found violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on May 8, 2012, was found to have sulfamethoxazole residues of 1.857 ppm in muscle and 1.477 ppm in liver, making the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, as FDA has no established tolerance for this drug in cattle.

The operation also held animals under insanitary conditions, failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4). Furthermore, the human drugs sulfamethoxazole and trimethoprim were used extralabelly on the calf without a licensed veterinarian's supervision, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C.F.R. 530.11(c). This extralabel use caused the drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

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