FDA WARNING_LETTER - Wabash Way Holsteins, LLC - June 18, 2014

On June 17-18, 2014, the FDA investigated Wabash Way Holsteins, LLC, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm sold two dairy cows for slaughter on March 3, 2014, which were found to have unsafe levels of desfuroylceftiofur (ceftiofur marker residue) in kidney tissue. One cow had 0.72 ppm and the other 1.8 ppm, exceeding the FDA tolerance of 0.4 ppm, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, indicating medicated animals with potentially harmful residues could enter the food supply, adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the firm illegally used the new animal drug Excede (ceftiofur crystalline free acid) extralabel. This use was not by or on the lawful order of a licensed veterinarian within a valid veterinarian/client/patient relationship, violating 21 C.F.R. 530.11(a). The extralabel use also resulted in illegal drug residues, violating 21 C.F.R. 530.11(d), and involved