FDA WARNING_LETTER - Maple Lane Dairy, Inc. - September 26, 2013

On September 18, 23, and 26, 2013, the FDA inspected Maple Lane Dairy, Inc., identifying violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on December 6, 2012, was found to have desfuroylceftiofur at 0.68 ppm in kidney tissue, exceeding the 0.4 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed unsanitary conditions, including a failure to maintain complete treatment records, indicating that medicated animals with potentially harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the firm adulterated new animal drugs, specifically penicillin G procaine and flunixin meglumine, by using them extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a). This included administering penicillin G procaine to a cow without following label directions for dose, injection site amount, duration, and frequency, and administering flunixin meglumine to a calf without following label directions for dose and route. These extralabel uses caused the drugs to be unsafe under 21 U.S.C. §