FDA WARNING_LETTER - El-Vi Farms, LLC - September 05, 2014

On September 2 and 5, 2014, the FDA inspected El-Vi Farms, LLC, and found violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on December 23, 2013, contained 4.16 ppm of desfuroylceftiofur in its kidney, exceeding the 0.4 ppm tolerance, 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, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the farm adulterated the new animal drug (b)(4) (ceftiofur hydrochloride) by using it extralabelly without following approved labeling dosage per injection site. This extralabel use resulted in an illegal drug residue and violated 21 CFR 530.11(d), as certain ceftiofur uses are prohibited for extralabel use in cattle per 21 CFR 530.41(a)(13)(ii). This rendered the drug unsafe and adulterated under 21 U.S.C. § 360b(a) and 2