FDA WARNING_LETTER - Vansridge Dairy - October 13, 2015

On October 6 and 13, 2015, the FDA inspected Vansridge Dairy, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on August 25, 2015, was found to have 0.058 ppm of penicillin in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, Vansridge Dairy adulterated the new animal drug Pro-Pen-G Injectable Suspension (penicillin G procaine, NADA #065-505) by administering it extralabelly without following dosing instructions or veterinarian supervision, and this extralabel use resulted in an illegal drug residue. This violated 21 C.F.R. 530.11(a) and (d), causing the drug to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(