FDA WARNING_LETTER - O'Dell Farms - June 12, 2014

On May 28, June 5, and June 12, 2014, the FDA inspected O'Dell Farms Partnership in Panama, New York. The inspection found the farm offered for sale an adulterated animal for slaughter as food, violating sections 402(a)(2)(C)(ii) and 402(a)(4) of the FD&C Act.

Specifically, a cow sold on September 24, 2013, for slaughter contained 0.73 ppm of desfuroylceftiofur in the kidney and 0.267 ppm of flunixin in the liver. These levels exceed the FDA tolerances of 0.4 ppm for desfuroylceftiofur and 0.125 ppm for flunixin, rendering the food adulterated.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply.

Furthermore, the farm adulterated new animal drugs, (b)(4) (flunixin meglumine) and (b)(4) (ceftiofur hydrochloride), by using them extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a) and resulting in illegal drug residues, violating 21 C.F.R. 530