FDA WARNING_LETTER - Jack Hall Farm - February 13, 2014

On February 11-13, 2014, the FDA inspected Jack Hall Farm, a dairy operation in Grayson, Kentucky, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a cow for slaughter on June 26, 2013, which USDA/FSIS analysis on June 27, 2013, found to contain 0.55 ppm of desfuroylceftiofur in the kidney, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), and 0.162 ppm of penicillin in the kidney, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510(a)). This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, making food adulterated under section 402(a)(4). Furthermore, the new animal drug Excenel RTU (ceftiofur hydrochloride sterile suspension, NADA140-890) was adulterated due to extralabel use. The farm administered Excenel RTU to a dairy cow without following indications or withdrawal times, and without