FDA WARNING_LETTER - Meerland Dairy Llc - August 09, 2012

On August 6, 7, and 9, 2012, the FDA inspected Meerland Dairy LLC and found violations of the Federal Food, Drug, and Cosmetic Act. A cull cow sold for slaughter on April 4, 2012, was found to have 9.556 ppm of tilmicosin in its liver, exceeding the 1.2 ppm tolerance and violating the prohibition of tilmicosin use in female dairy cattle 20 months or older. This rendered the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including incomplete treatment records and inadequate segregation of medicated animals, leading to the likelihood of drug-residue-bearing animals entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug Micotil (tilmicosin injection) NADA 140-929 was adulterated because it was used extralabelly without following approved labeling or veterinarian's directions. This extralabel use was not under veterinary supervision (21 C.F.R. 530.11(a)) and resulted in an illegal drug residue (21 C.F.R. 530.11(c)), making the