FDA WARNING_LETTER - Lomeo, Simon J. - October 22, 2009

On October 8, 20, 21, and 22, 2009, the FDA inspected Simon J. Lomeo's cattle operation in Whitesboro, NY, and found violations of the Federal Food, Drug, and Cosmetic Act. Two dairy cows sold for slaughter on December 18, 2008, were found to be adulterated. Tissue samples from one cow contained sulfadimethoxine (3.63 ppm liver, 2.15 ppm muscle), sulfamethazine (2.89 ppm liver, 1.64 ppm muscle), and flunixin (0.2197 ppm liver), exceeding FDA tolerances (0.1 ppm for sulfadimethoxine and sulfamethazine, 0.125 ppm for flunixin). The second cow had sulfadimethoxine (6.71 ppm liver, 3.91 ppm muscle) and flunixin (0.4456 ppm liver), also above tolerances.

The operation also held animals under insanitary conditions, failing to maintain treatment records, which could lead to contaminated food entering the supply. Additionally, new animal drugs (Albon Boluses, Liquamycin LA-200 Injection, Prevail Injectable Solution, Supra Sulfate III Sustained Release Boluses, Pen-Aqueous Injectable Suspension) and medicated feed (AS700 2+2) were used in