FDA WARNING_LETTER - Diamond B Dairy - January 17, 2014

On January 10, 16, and 17, 2014, the FDA inspected a dairy operation in Wendell, Idaho, and found violations of the Federal Food, Drug, and Cosmetic Act. The operation sold a cow for slaughter on July 25, 2013, which was found to have 24.73 ppm of sulfamethazine in its kidney tissue, exceeding the 0.1 ppm tolerance for uncooked cattle tissues. This drug is not approved for use in lactating dairy cows, making the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, indicating that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615, was adulterated because it was used extralabelly on a lactating dairy cow, which is prohibited by 21 C.F.R. 530.41(a)(9). This use was not by or on the order of a licensed veterinarian within a valid veterinarian/client/patient relationship, causing the drug to be unsafe under section 51