FDA WARNING_LETTER - Double W Dairy - July 11, 2013

An FDA investigation conducted on July 9 and 11, 2013, at Double W Dairy, LP in Holyoke, Colorado, revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of a dairy cow for slaughter with penicillin residues (0.120 ppm) exceeding the established tolerance (0.05 ppm), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The firm was also cited for holding animals under insanitary conditions, specifically failing to maintain complete treatment records and verify withdrawal times, which could lead to medicated animals with harmful residues entering the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4). Additionally, the new animal drug (b)(4) was adulterated due to extralabel use not under the supervision of a licensed veterinarian (21 CFR 530.11(a)) and resulting in illegal drug residues (21 CFR 530.11(d)), making the drug unsafe and adulterated under 21 U.S.C. §§ 360b(a) and 351(a)(5). Finally, the firm provided a false "drug affidavit" certifying no illegal drug residues for the violative animal, which is prohibited by 21 U.S.C. § 331(h). Double W Dairy must take prompt corrective actions, establish preventative procedures, and respond to the FDA within fifteen working days, or face potential regulatory actions like seizure or injunction.