FDA WARNING_LETTER - Spurlock Farms - August 18, 2014

On August 15 and 18, 2014, the FDA inspected Spurlock Farms, a cattle raising operation. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on March 11, 2014, Spurlock Farms sold a Charolais bull for slaughter. USDA/FSIS analysis of tissue samples from this animal found 0.66 ppm of desfuroylceftiofur (ceftiofur marker residue) in the kidney tissue, exceeding the FDA tolerance of 0.4 ppm. This rendered the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found that Spurlock Farms held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. 342(a)(4). A key deficiency was the failure to maintain complete treatment records.

Furthermore, Spurlock Farms adulterated the new animal drug (b)(4) (ceftiofur hydrochloride sterile suspension) by using it extralabelly without following the approved label's withdrawal time and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (d). This extralabel use resulted in an