FDA WARNING_LETTER - Hi Hills Farm - January 04, 2013

On December 17 and 19, 2012, and January 4, 2013, the FDA investigated Hi Hills Farm, a dairy operation owned by Timothy A. Stitzlein. The investigation found multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on July 2, 2012, a bob veal calf sold for slaughter by Hi Hills Farm was found to have 46.82 parts per million (ppm) of neomycin in its kidney tissue. This significantly exceeds the 7.2 ppm tolerance for cattle and is an unacceptable level for veal calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain treatment records for medicated animals and an inadequate inventory of drugs, leading to the likelihood of contaminated animals entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, Hi Hills Farm adulterated the drug IBA Scour Treat 10g by using it extra-label on a bob veal calf without a licensed veterinarian's supervision, in violation of 21 C.F.R. 530.11(a). The extra-label use was also in or on feed (21 C.