FDA WARNING_LETTER - Coldstream Farms L.L.C. - March 31, 2010

On March 29 and 31, 2010, the FDA investigated a dairy operation at 2304 Valley Highway, Deming, Washington, identifying violations of the Federal Food, Drug, and Cosmetic Act. The operation offered for sale adulterated animals for slaughter.

Specifically, on July 8, 2009, a dairy cow sold for slaughter contained 0.39 ppm of penicillin in the kidney, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering it adulterated under section 402(a)(2)(C)(ii) of the Act. On November 19, 2009, another dairy cow sold for slaughter contained 0.3279 ppm of flunixin in the liver, exceeding the 0.125 ppm tolerance (21 C.F.R. 556.286), also causing adulteration under the same section.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the new animal drug Penicillin Injection (Penicillin G Procaine Injectable Suspension), NADA 065-010, was adulterated due