FDA WARNING_LETTER - Merlin R. Yoder - March 13, 2015

The FDA conducted an inspection of Merlin R. Yoder and Mary J. Yoder's dairy operation in Colon, Michigan, on February 25 and March 13, 2015. The inspection revealed several violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on November 5, 2014, was found to be adulterated, with tissue samples showing gentamicin in kidney tissue and 1.38 ppm tilmicosin in the liver. This exceeded the 1.2 ppm tilmicosin tolerance for cattle liver, which does not apply to female dairy cattle 20 months or older, and no tolerance exists for gentamicin, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The firm also held animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4), exemplified by a failure to maintain treatment records. Furthermore, the firm adulterated new animal drugs, Bactracillin G and VetaMeg, through extralabel use not supervised by a licensed veterinarian, violating 21 C.F.R. § 530.11(a). This non-conformance with approved labeling and 21 C.F.R. Part 530 caused the drugs to be unsafe and adulterated under 21 U.S.C. §§ 360b(a) and 351(a)(5). The FDA requires prompt corrective actions and procedures to prevent recurrence, with a written response due within 15 working days detailing steps taken and providing documentation, or face potential regulatory actions like seizure or injunction.