FDA WARNING_LETTER - Gonzalez Dairy, LLC - September 11, 2008

On September 9-11, 2008, the FDA inspected Gonzalez Dairy, LLC, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A Holstein cow sold for slaughter on July 3, 2008, was found to have 10.19 ppm of Sulfamethazine in its liver, exceeding the 0.1 ppm tolerance (21 C.F.R. § 556.670), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain an adequate system to ensure medicated animals are withheld from slaughter for appropriate withdrawal periods. The dairy failed to review treatment records for the aforementioned Holstein cow before sale, leading to adulterated food under 21 U.S.C. § 342(a)(4).

Furthermore, the dairy adulterated Sulfamethazine by using it extralabelly without veterinary supervision, violating 21 C.F.R. § 530.11(a). The Holstein cow received three 32.1 gram boluses daily for three days, exceeding the label's recommendation of no more than five boluses within 72 hours and violating the 12-day withdrawal time, resulting in illegal drug residue (21 C.F.R