FDA WARNING_LETTER - Griebel Dairy Farms - February 07, 2012

On January 10 and February 7, 2012, the FDA inspected Griebel Dairy Farms, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on October 24, 2011, was found to have 0.138 ppm of flunixin in its liver tissue, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, as FDA has no established tolerance for flunixin in veal calves.

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Flunazine (Flunixin Meglumine Injectable Sterile Solution) was adulterated under section 501(a)(5) of the FD&C Act. Griebel Dairy Farms used Flunazine extralabelly by administering it to a veal calf, a class of animal not specified on the approved labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal residue, violating 21 C.F.R.