FDA WARNING_LETTER - R & R Holsteins, LLC (Dairy #3) - April 13, 2017

On April 7, 10, and 13, 2017, the FDA investigated a dairy operation in Wendell, Idaho, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act.

A cow sold for slaughter on August 12, 2016, was found to be adulterated. Tissue analysis by USDA/FSIS revealed desfuroylceftiofur (ceftiofur marker) at 17.78 ppm in kidney tissue (tolerance 0.4 ppm) and flunixin at 1.59 ppm in liver tissue (tolerance 0.125 ppm). This constitutes adulteration under 21 U.S.C. § 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, lacking an adequate system to ensure drug withdrawal times. Deficiencies included incomplete treatment records (missing drug amount, route, injection site amount, withdrawal times, administrator, and condition treated) and an inadequate drug inventory system. This renders food adulterated under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drugs Excenel RTU EZ and Vetameg were adulterated due to extralabel use not in compliance with approved labeling. Specifically, these drugs were administered to the aforementioned cow without following the stated withdrawal period and without the supervision of a licensed veterinarian, violating