FDA WARNING_LETTER - GMC Dairy Farms - March 17, 2015

On March 5 and 17, 2015, the FDA inspected GMC Dairy Farms, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm offered two adulterated dairy cows for slaughter. One cow, sold around November 12, 2014, had 1.91 ppm of desfuroylceftiofur in its kidney, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113). Another cow, sold around December 1, 2014, had 3.7 ppm of oxytetracycline in muscle and 12.7 ppm in kidney, exceeding tolerances of 2 ppm and 12 ppm respectively (21 C.F.R. 556.500). These levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, leading to adulterated food under section 402(a)(4). Additionally, the new animal drugs Ceftiofur and oxytetracycline were adulterated under section 501(a)(5) because they were used extralabelly without veterinary supervision or adherence to withdrawal times and indications for use, violating 21 C.F.R.