FDA WARNING_LETTER - Double A Dairy, LLC - July 24, 2015

On July 22 and 24, 2015, the FDA inspected Ron Aardema and Donald Aardema, Jr.'s dairy operation in Jerome, Idaho, and found violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the sale of an adulterated dairy cow for slaughter on May 18, 2015. USDA/FSIS analysis of the animal's liver tissue revealed sulfadimethoxine at 0.334 ppm, exceeding the FDA tolerance of 0.1 ppm, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

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

Furthermore, the new animal drug Albon (sulfadimethoxine) was adulterated due to extralabel use. The firm administered Albon to dairy cows for pneumonia and foot rot without following approved labeling or veterinarian's orders, resulting in an illegal drug residue. This extralabel use violated 21 C.F.R. 530.11(d) and 21 C.F.R. 530.41(a)(9),