FDA WARNING_LETTER - Double Dutch Dairy, LLC - May 14, 2013

On May 2, 8, and 14, 2013, the FDA investigated Dutch Dairy, located at 17215 Wild Road, Helendale, CA. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on February 13, 2013, Dutch Dairy sold a dairy cow for slaughter that was found to have desfuroylceftiofur at 3.73 ppm in kidney tissue, exceeding the FDA tolerance of 0.4 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. This was evidenced by a failure to maintain complete treatment records.

Furthermore, the new animal drug (b)(4) (ceftiofur hydrochloride) was adulterated because it was used in an extralabel manner without following the withdrawal period and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (d). This extralabel use resulted in an illegal drug residue, causing the drug to be unsafe under section 51