Ed Vander Woude Dairy – FDA Warning Letter, Sep 23, 2013

On November 14, 2013, the FDA issued a Warning Letter to Edward P. and Janice C. Vander Woude, owners of Ed Vander Woude Dairy, following an investigation conducted from August 8 to September 23, 2013. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, a Holstein cow sold for slaughter on March 26, 2013, was found to have sulfadimethoxine in its liver tissue at (b)(4) parts per million (ppm), exceeding the established tolerance of 0.10 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the dairy operation was found to hold animals under insanitary conditions, specifically failing to maintain complete treatment records. This practice makes it likely that medicated animals with harmful drug residues could enter the food supply, causing food to be adulterated under section 402(a)(4) of the FD&C Act.

The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions such as seizure and/or injunction. A written response detailing corrective steps must be submitted to the FDA within fifteen working days of receiving the letter.