FDA WARNING_LETTER - Kevin Klug - July 03, 2019

On June 10 and July 3, 2019, the FDA investigated Mr. Kevin J. Klug's dairy operation in Wynot, Nebraska, identifying violations of the Federal Food, Drug, and Cosmetic Act.

A cow sold for slaughter on January 3, 2019, was found to be adulterated. USDA/FSIS analysis revealed Desfuroylceftiofur at 1.216 ppm in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. § 556.113(b)(3)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the new animal drug Ceftiofur Crystalline Free Acid was adulterated. Mr. Klug administered the drug extralabelly, violating 21 C.F.R. Part 530. Specifically, the cow received a second dose on December 20, 2018, instead of 72 hours after the initial December 13, 2018 dose. The dose was based on an estimated 1200 lbs, but the cow weighed 850 lbs, resulting in an overdose. The drug was administered on the side of the tailhead, not the approved subcutaneous ear injection site. This extralabel