FDA WARNING_LETTER - Fessenden Dairy, LLC - April 30, 2014

On April 23 and 30, 2014, the FDA inspected Fessenden Dairy, LLC, and found violations of the Federal Food, Drug, and Cosmetic Act. A heifer calf sold for slaughter was adulterated, containing unsafe levels of tulathromycin in kidney tissue, for which no tolerance is established in veal calves. This violates section 402(a)(2)(C)(ii) of the FD&C Act.

The dairy also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically by failing to maintain complete treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug tulathromycin was adulterated because it was used extralabelly without following approved labeling or a veterinary prescription. The administration to a heifer calf did not conform to the animal class specified in the labeling, was not under licensed veterinarian supervision (violating 21 C.F.R. 530.11(a)), and resulted in an illegal drug residue (violating 21 C.F.R. 530.11(c)). This rendered the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

Fessenden Dairy must take prompt action to