FDA WARNING_LETTER - Yurkanin, John B - January 25, 2010

On January 13-25, 2010, the FDA inspected John B. Yurkanin's dairy operation. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on September 14, 2009, a dairy cow sold for slaughter was found to have sulfamethazine residues of 4.02 ppm in liver tissue and 1.31 ppm in muscle tissue, exceeding the 0.1 ppm tolerance. This rendered the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. 342(a)(4). This was evidenced by a failure to maintain complete treatment records, lacking details on drug used, dosage, administration route, and administrator.

Furthermore, the new animal drug Supra Sulfa III (Antibacterial Sulfamethazine Sustained Release Bolus) was adulterated. The drug was used extralabelly on a dairy cow without following approved labeling indications and withdrawal periods, and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This extralabel use resulted in an illegal drug residue, violating 21 C.