FDA WARNING_LETTER - Gallagher Farms, LLC - February 26, 2014

On February 18, 25, and 26, 2014, the FDA inspected Gallagher Farms, LLC, a dairy farm in Deansboro, New York. The inspection revealed several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the farm sold a dairy cow for slaughter on May 28, 2013, which was found to have 1.967 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 animal adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the farm failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

The farm also engaged in illegal extralabel drug use of (b)(4) (tilmicosin phosphate injection), (b)(4) (penicillin G procaine Injectable Suspension), and (b)(4) (oxytetracycline). These drugs were administered without following approved labeling for animal class, withdrawal periods, dose, amount injected per site, and indications for use. Crucially, these extralabel uses