Da Rosa Dairy – FDA Warning Letter, Dec 19, 2012

On December 11, 12, and 19, 2012, the FDA inspected Da Rosa Dairy in Turlock, California, and found significant violations of the Federal Food, Drug, and Cosmetic Act.

A bob veal calf sold for slaughter on August 8, 2012, contained 38.5 ppm of neomycin in kidney tissue, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for bob veal calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The dairy also held animals under insanitary conditions, failing to maintain complete treatment records, making food from these animals adulterated under 21 U.S.C. § 342(a)(4).

Furthermore, the dairy illegally used new animal drugs, including (b)(4) (neomycin sulfate and oxytetracycline hydrochloride) and (b)(4) (oxytetracycline hydrochloride injection), in an extralabel manner. (b)(4) was administered to a bob veal calf without following approved labeling, resulting in an illegal residue and violating 21 C.F.R. 530.11(b) and (c). (b)(4) was administered to dairy cows without veterinarian supervision, violating 21 C.F.R. 530.