FDA WARNING_LETTER - Griffith Dairy - February 26, 2014

On February 24-26, 2014, the FDA inspected Griffith Dairy, a dairy and heifer raising operation in Fort Morgan, Colorado. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on October 17, 2013, Griffith Dairy sold a dairy cow for slaughter that contained gentamicin in its kidney tissue, a drug for which FDA has not established a tolerance in cattle. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain treatment records for medicated animals, which could lead to harmful drug residues entering the food supply, violating section 402(a)(4) of the FD&C Act.

Furthermore, Griffith Dairy adulterated the new animal drug gentamicin by using it in an extralabel manner without following approved labeling or veterinarian's directions, and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and (c). This extralabel use resulted in illegal drug residues, making the drug unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

Additionally, on October 17, 2013, Stephen F. Griffith provided