FDA WARNING_LETTER - Dutch Valley Farms - June 24, 2010

On June 22-24, 2010, the FDA inspected Dutch Valley Farms, a dairy operation in Clovis, New Mexico. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on (b)(4) was found to have 0.333 ppm Sulfadimethoxine in its liver tissue, exceeding the 0.1 ppm tolerance (21 C.F.R. 556.640), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The operation also held animals under insanitary conditions, failing to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the Act.

Furthermore, the new animal drug (b)(4) Sulfadimethoxine was adulterated. The firm used it extralabelly by administering nearly double the recommended dose to a dairy cow without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and causing the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Act, respectively.

Dutch Valley Farms must take prompt action to correct these violations and