FDA WARNING_LETTER - F.B. Indian Ridge Dairy - July 08, 2008

On June 24 and July 8, 2008, the FDA investigated F. B. Indian Ridge Dairy in Energy, Texas, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy sold adulterated animals for slaughter as food.

Specifically, a dairy cow sold on March 7, 2008, contained tetracycline at 16.84 ppm in kidney tissue (tolerance 12 ppm) and flunixin at 2.004 ppm in liver and 0.046 ppm in muscle (flunixin liver tolerance 0.125 ppm). Another dairy cow sold on March 7, 2008, had flunixin at 0.304 ppm in the liver (tolerance 0.125 ppm). These levels exceed FDA tolerances, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including failure 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 dairy engaged in extralabel use of tetracycline and flunixin without veterinary supervision, violating 21 C.F.R. 530