Scheenstra Farms Inc – FDA Warning Letter, Nov 30, 2007

An FDA inspection on November 27 and 30, 2007, revealed that a dairy cow sold for slaughter on May 14, 2007, by Mr. Scheenstra was adulterated. USDA/FSIS analysis of tissue samples from the slaughtered animal on May 15, 2007, found ampicillin residues in the liver at 0.04 ppm and kidney at 0.70 ppm, exceeding the established tolerance of 0.01 ppm. This violates sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), rendering the food adulterated.

The inspection also identified inadequate conditions, indicating that medicated animals with harmful drug residues are likely to enter the food supply. Specifically, Mr. Scheenstra lacked an adequate system to ensure appropriate withdrawal times for medicated animals, evidenced by incomplete treatment records. This constitutes adulteration under section 402(a)(4) of the Act.

Furthermore, the new animal drug ampicillin was adulterated under section 501(a)(5) of the Act due to extralabel use not conforming to approved labeling and without veterinary supervision, specifically for mastitis, violating 21 C.F.R. 530.11(a). This extralabel use also resulted