FDA WARNING_LETTER - Inez Mattison - March 14, 2011

On March 10, 11, and 14, 2011, the FDA inspected Heritage Hill Farm, a dairy operation owned by Inez Mattison. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on November 15, 2010, a bob veal calf sold by Heritage Hill Farm for slaughter was found to have sulfamethoxazole at 0.193 ppm in liver tissue and 0.213 ppm in muscle tissue, and gentamicin in kidney tissue. Since FDA has not established tolerances for these drugs in bob veal calves, the animal was deemed adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including failure to maintain treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drugs (b)(4) (gentamicin sulfate) and (b)(4) were adulterated because they were used extralabelly without following approved labeling or a licensed veterinarian's directions. This included administering (b)(4) to a bull calf without proper dose, frequency, or withdrawal period, and (b)(4) without the correct withdrawal period. These extralabel uses were not under veterinary