FDA WARNING_LETTER - Butternut Brook Farm - November 22, 2011

On November 7-22, 2011, the FDA investigated Butternut Brook Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm sold three bob veal calves for slaughter on February 23, 2011, which were slaughtered on February 24, 2011. USDA/FSIS analysis found neomycin residues in their kidney tissues at 19.99 ppm, 22.25 ppm, and 31.14 ppm, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves. This rendered the animals adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed the farm failed to maintain treatment records, leading to adulterated food under 21 U.S.C. § 342(a)(4). Furthermore, the farm engaged in extralabel use of a Medicated Supplement containing neomycin and oxytetracycline by administering it to bob veal calves, an animal class not specified on the approved labeling. This extralabel use was not under a licensed veterinarian's supervision and resulted in illegal residues, violating 21 C.F.R. 530.11(a) and (c). This caused the drugs to be unsafe and adulterated under 21 U.S.C.