FDA WARNING_LETTER - Domina, Gary - March 14, 2008

On June 19, 2008, the FDA issued a Warning Letter to Gary Domina following a March 11-14, 2008, investigation of his dairy operation in Enosburg, Vermont. The investigation confirmed that Domina offered an animal for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specifically, on December 17, 2007, a dairy cow sold by Domina was found to have 9.78 ppm of dihydrostreptomycin in its kidney tissue, exceeding the established tolerance of 2.0 ppm (21 C.F.R. 556.200). This rendered the animal adulterated.

The investigation also revealed that Domina's operation lacked an adequate system to ensure medicated animals were withheld from slaughter for appropriate periods, leading to potentially harmful drug residues entering the food supply. A key deficiency was the failure to maintain treatment records, which constitutes adulteration under Section 402(a)(4) of the Act.

Furthermore, Domina adulterated the new animal drug dihydrostreptomycin under section 501(a)(5) of the Act by failing to use it in conformance with its approved application. The drug, Quartermaster® brand