FDA WARNING_LETTER - Wild Rose Dairy, LLC - November 20, 2013

On November 19 and 20, 2013, the FDA inspected Wild Rose Dairy, LLC, in La Farge, Wisconsin, and found violations of the Federal Food, Drug, and Cosmetic Act. The company offered for sale an adulterated dairy cow for slaughter on April 1, 2013, which contained 0.629 ppm of penicillin in kidney tissue, exceeding the 0.05 ppm tolerance (21 CFR 556.510(a)). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the FDA determined that the company held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). Specifically, Wild Rose Dairy failed to maintain and review complete treatment records to verify withdrawal periods before slaughter.

The company also adulterated the new animal drug (b)(4) (Sterile Penicillin G procaine Injectable Suspension) by using it extralabelly without following approved labeling for dose and amount per injection site. This extralabel use was not under the supervision of a licensed veterinarian (violating 21 CFR 530.11(a)) and resulted in an illegal drug residue (violating 21 CFR 530.11(d)). This caused the drug to