FDA WARNING_LETTER - Dairyland Farm, LLC - April 28, 2008

An FDA inspection of Dairyland Farm, LLC, conducted on April 8, 15, and 28, 2008, revealed that the company offered animals for slaughter as food that were adulterated. Specifically, two dairy cows consigned for slaughter on January 14, 2008, and February 5, 2008, respectively, had flunixin residues in their livers exceeding the established tolerance of 0.125 ppm (4.779 ppm and 1.331 ppm, respectively). This violates sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection also found that Dairyland Farm lacked an adequate system to ensure medicated animals were withheld from slaughter for appropriate periods, failing to maintain complete treatment records including dosage, administration route, administrator identity, and withholding periods. This caused food from these animals to be adulterated under section 402(a)(4) of the Act.

Furthermore, the company adulterated the new animal drug flunixin meglumine by using it in an extralabel manner without the supervision of a licensed veterinarian and contrary to approved labeling (administering to a dry dairy cow), resulting in illegal drug residues. This constitutes an unsafe use under section 512(a) and adulteration under