FDA WARNING_LETTER - Ardounie Farms

On June 6, 2013, the FDA issued a Warning Letter to Ardounie Farms following a May 6, 2013, investigation of their dairy farm. The letter details violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a bob veal calf sold for slaughter on February 13, 2013, was found to have Flunixin in its kidney tissue by USDA/FSIS analysis. FDA has no established tolerance for Flunixin in veal calf edible tissues, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation revealed insanitary conditions, including a failure to maintain treatment records for calves, indicating that medicated animals with potentially harmful drug residues are likely to enter the food supply, which constitutes adulteration under section 402(a)(4) of the FD&C Act.

Ardounie Farms also adulterated the new animal drug Flu-nix-D (Flunixin Meglumine Injectable Sterile Solution) by using it extralabelly without following approved labeling for animal class. 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. 530.1