FDA WARNING_LETTER - Kranenburg Dairy - July 22, 2010

On September 24, 2010, the FDA issued a Warning Letter to Harry Van Kranenburg, owner of Kranenburg Dairy, following an investigation conducted from July 20-22, 2010. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 26, 2010, a Holstein dairy cow sold for slaughter by Kranenburg Dairy was found to have a Ceftiofur residue level of 44.01 ppm in the kidney, significantly exceeding the FDA tolerance of 0.4 ppm for desfuroylceftiofur in cattle kidney tissues (21 C.F.R. § 556.113). This rendered the animal adulterated under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the dairy was cited for holding animals under insanitary conditions, leading to the likelihood of medicated animals with harmful drug residues entering the food supply. The investigation found a lack of an adequate system to ensure proper drug withdrawal times. Specifically, treatment records for medicated dairy cows were incomplete, lacking details such as dosage, route of administration, identity of the individual administering the drug, and required withdrawal times. This constitutes adulteration under section 402(a)(4) of the Act.

Kranenburg Dairy is required to take prompt action to correct these violations and establish procedures