FDA WARNING_LETTER - Spring Water Farm, LLC - October 26, 2012

On October 24 and 26, 2012, the FDA inspected Spring Water Farm, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on August 16, 2012, was found to have desfuroylceftiofur in its kidney at 1.36 ppm, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The farm also held animals under unsanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the farm illegally used new animal drugs Excede (ceftiofur) and Tetrasol (tetracycline hydrochloride) extralabelly. Excede was administered without following approved labeling or veterinary directions, resulting in illegal residues (21 C.F.R. 530.11(d)). Tetrasol was administered without following conditions of use, route, dosage, or animal class, and not under veterinarian supervision (21 C.F.R. 53