FDA WARNING_LETTER - V and L Dairy - August 15, 2012

On August 13 and 15, 2012, the FDA inspected a dairy operation in Wendell, Idaho, and found violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on April 24, 2012, was found to have 3.371 ppm of tilmicosin in its liver tissue, exceeding the 1.2 ppm tolerance and rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The use of tilmicosin in female dairy cattle 20 months or older has no acceptable residue level.

The operation also held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug tilmicosin was adulterated because it was used extralabelly without following approved labeling for animal class, treatment frequency, or drug amount per injection site, and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (c). This extralabel use resulted in an illegal drug residue, making the drug unsafe under 21 U.S.C. § 36