FDA WARNING_LETTER - Van Dyk Dairy #1 - January 03, 2008

An FDA inspection on January 2-3, 2008, of a dairy operation in Jerome, Idaho, revealed significant violations. A dairy cow sold for slaughter on October 12, 2007, was found to have sulfadimethoxine at 0.14 ppm in liver tissue, exceeding the 0.1 ppm tolerance (21 CFR 556.640). Additionally, sulfamethazine was detected at 0.46 ppm in liver and 0.19 ppm in muscle, with no established tolerance for lactating dairy cows. These residues render the animal adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The operation lacked an adequate system to prevent medicated animals with harmful drug residues from entering the food supply, specifically failing to maintain complete treatment records and observe appropriate withdrawal times. Furthermore, the new animal drug Sustain III (sulfamethazine) Bolus was adulterated under section 501(a)(5) of the Act due to extralabel use not conforming to approved labeling. This extralabel use, including failure to follow withdrawal periods and lack of licensed veterinarian supervision, violated 21 CFR 530.11(a) and resulted in illegal drug residues, violating 21 CFR 530.11(