FDA WARNING_LETTER - Doughty Valley Holsteins LLC - February 11, 2014

On January 31, February 6, and 11, 2014, the FDA investigated Doughty Valley Holstein, LLC.'s dairy operation. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on July 22, 2013, a bob veal calf sold for slaughter contained sulfamethoxazole in its kidney tissue, for which FDA has no established tolerance in calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the human drug Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, was used extralabelly without veterinary supervision and without adhering to the prescribed withdrawal period, resulting in illegal drug residue. This violated 21 C.F.R. 530.11(a) and (c), and rendered the drug unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. The addition of this human drug to animal feed (milk and water solution) for calves also constituted adulter