FDA WARNING_LETTER - Hart of Texas Cattle Feeders, LLC - April 10, 2014

On April 8-10, 2014, the FDA inspected Hart of Texas Cattle Feeders, LLC, finding violations of the FD&C Act. The firm sold seven culled cattle for slaughter on November 6, 2013. USDA/FSIS analysis of one animal's kidney tissue revealed 11.55 ppm of desfuroylceftiofur (ceftiofur marker residue), exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113), rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found insanitary conditions, specifically incomplete treatment records lacking accurate withdrawal times, leading to adulterated food under 21 U.S.C. 342(a)(4). Furthermore, the firm adulterated the new animal drug (b)(4) Sterile Suspension (NADA (b)(4)) by extralabel use without following approved labeling or a veterinarian's prescription, and not under veterinary 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), making the drug unsafe (21 U.S.C. 36