FDA WARNING_LETTER - Cheyenne Dairy No. 2 - January 14, 2008

An FDA inspection of Cheyenne Dairy No. 2, owned by Mr. David A. Hoekstra, conducted from January 9-14, 2008, revealed significant violations concerning adulterated animals sold for slaughter and unsafe/adulterated new animal drug use. The inspection confirmed that animals offered for food were adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, a cow sold on October 22, 2007, had Penicillin residues (0.61 ppm in kidney) exceeding the 0.05 ppm tolerance (21 CFR § 556.510). Another cow sold on September 28, 2007, showed Flunixin residues (0.611 ppm in liver, 0.038 ppm in muscle) exceeding tolerances (0.125 ppm liver, 0.025 ppm muscle) (21 CFR § 556.286).

The dairy also lacked an adequate system to ensure proper drug withdrawal times, leading to medicated animals with potentially harmful residues entering the food supply, and failed to maintain complete treatment records. Furthermore, the new animal drug Penicillin G Procaine Injectable Suspension U.S.P. was rendered unsafe and adulterated (sections 512(a) and 501(a)(5) of the Act) due to extralabel use not conforming to approved labeling. This included administering three times the recommended dose without licensed veterinarian supervision (21 C.F.R. § 530.11(a)) and resulting in illegal drug residues (21 C.F.R. § 530.11(d)). The FDA requires prompt corrective action and a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence, including documentation. Failure to comply may lead to regulatory actions such as seizure or injunction.