FDA WARNING_LETTER - Meadowlark Dairy L.L.C. - December 07, 2011

On December 6 and 7, 2011, the FDA inspected Meadowlark Dairy LLC in De Pere, Wisconsin, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation was offering an adulterated animal for slaughter. Specifically, a dairy cow sold on August 10, 2011, contained desfuroylceftiofur at 0.81 ppm and dihydrostreptomycin at 5.9 ppm in kidney tissue, exceeding the FDA tolerances of 0.4 ppm and 2.0 ppm, respectively. This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records and ensure withdrawal times were observed, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). Furthermore, the firm adulterated the new animal drug (b)(4) brand of penicillin-dihydrostreptomycin in oil by using it extra-label without a licensed veterinarian's supervision and resulting in illegal drug residues, violating 21 CFR 530.11(a) and (d), and sections 512(a) and 501(a)(5) of the Act.

Meadowlark Dairy LLC must take prompt action to correct these violations and