FDA WARNING_LETTER - Lakeview Dairy Farms - February 11, 2008

An FDA inspection on January 29 and February 11, 2008, at a dairy operation in Bakersfield, California, revealed multiple violations. A dairy cow consigned for slaughter on July 23, 2007, was found to have Flunixin residues in liver tissue at 0.448 ppm and muscle tissue at 0.063 ppm, exceeding the established tolerances of 0.125 ppm and 0.025 ppm, respectively. This rendered the animal adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The operation lacked an adequate system to prevent medicated animals with harmful drug residues from entering the food supply, specifically failing to maintain complete treatment records. This also constitutes adulteration under section 402(a)(4) of the Act.

Furthermore, the new animal drug Flunixin Meglumine Injectable Solution was adulterated under section 501(a)(5) of the Act due to extralabel use not conforming to approved labeling and 21 C.F.R. Part 530. Specifically, the drug was administered via intramuscular injection instead of the veterinarian's prescribed intravenous route, violating 21 C.F.R. 530.11(a), and resulted