FDA WARNING_LETTER - Kelly Hills Dairy Inc - September 10, 2014

On September 10, 2014, the Kansas Department of Agriculture (KDA), under contract with the FDA, investigated Kelly Hills Dairy, Inc. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on August 6, 2014, Kelly Hills Dairy sold a culled dairy cow for slaughter. USDA/FSIS analysis found 0.515 ppm of penicillin residue in the kidney, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Bactracillin G (NADA #065-010) was adulterated. Kelly Hills Dairy used Bactracillin G extralabelly by not following the recommended dose and treating a condition not on the approved label. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.1