FDA WARNING_LETTER - Elma Dairy, LLC - March 12, 2010

On March 10 and 12, 2010, the FDA investigated a dairy operation at 144 North Bl9ckhouse Road, Elma, Washington, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the sale of an adulterated dairy cow for slaughter on September 21, 2009. Tissue samples from this animal, identified with retain tag (b)(4), showed desfuroylceftiofur in the kidney at 1.04 ppm (tolerance 0.4 ppm) and sulfadimethoxine in the liver at 0.441 ppm (tolerance 0.1 ppm). This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also found insanitary conditions, specifically inadequate record-keeping for treatments and an insufficient drug inventory system, leading to the likelihood of medicated animals with harmful residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the new animal drugs ceftiofur hydrochloride and sulfadimethoxine were adulterated under section 501(a)(5) and rendered unsafe under section 512(a) due to extralabel use. The dairy administered these drugs without following approved labeling withdrawal periods or conditions of use, and critically, without the supervision of a licensed