FDA WARNING_LETTER - Van Kooten Dairy - July 29, 2015

On July 28-29, 2015, the FDA inspected Van Kooten Dairy, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on March 20, 2015, was found to have adulterated meat due to unsafe levels of new animal drugs. USDA/FSIS analysis revealed 34.7 ppm of oxytetracycline in kidney tissue (tolerance 12.0 ppm) and 5.48 ppm of flunixin in liver tissue (tolerance 0.125 ppm). This violates 21 U.S.C. 342(a)(2)(C)(ii).

The dairy also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically failing to maintain complete treatment records, violating 21 U.S.C. 342(a)(4).

Furthermore, the firm adulterated new animal drugs (Oxytetracycline and Flunixin) by using them extralabelly without veterinary supervision and not adhering to approved labeling (e.g., withdrawal periods, route of administration), resulting in illegal drug residues. This violates 21 C.F.R. 530.11(a) and (d), and renders the drugs unsafe and adulterated under 21 U.S.C. 3