FDA WARNING_LETTER - Dick Van Dam Dairy - March 25, 2011

On March 3 and March 25, 2011, the FDA inspected Dick Van Dam Dairy, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on January 10, 2011, contained 4.94 ppm of flunixin in liver tissue, exceeding the 0.125 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The dairy also held animals under insanitary conditions, failing to maintain treatment records and records of animals sold, making food from these animals adulterated per 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug flunixin meglumine was adulterated because it was used extralabelly without veterinary supervision and not according to approved labeling, violating 21 C.F.R. 530.11(a) and (d), and resulting in an illegal drug residue. This caused the drug to be unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5).

Additionally, on January 10, 2011, a false guaranty was provided stating no cattle had illegal drug