FDA WARNING_LETTER - Superior Cattle Feeders LLC - June 18, 2014

On June 5, 12, and 18, 2014, the FDA investigated Superior Cattle Feeders, LLC, finding multiple violations of the Federal Food, Drug, and Cosmetic Act. A steer sold for slaughter on December 26, 2013, contained desfuroylceftiofur (ceftiofur marker residue) at 86.48 ppm in kidney tissue, exceeding the 0.4 ppm tolerance, rendering the food adulterated under Section 402(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, indicating medicated animals with harmful residues could enter the food supply, thus adulterating food under Section 402(a)(4).

Furthermore, the new animal drug (b)(4) (ceftiofur hydrochloride) Injectable Sterile Suspension, (b)(4), was adulterated. It was used extralabelly on a steer without following the approved labeling's dose and withdrawal period, and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a). This extralabel use resulted in an illegal drug residue, violating 21 C.F.R. 530.11(d), and is prohibited for extralabel use in cattle by 21 C.F.R. 530.4