FDA WARNING_LETTER - Gonsalves Ranch - October 19, 2012

The FDA conducted an inspection of Gonsalves Ranch, a beef cattle operation in Modesto, California, on October 10, 17, and 19, 2012. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, primarily concerning the sale of an adulterated animal for slaughter and improper drug use. Specifically, an Angus heifer calf sold on March 23, 2012, was found to have sulfadimethoxine residues (0.192 ppm, exceeding the 0.1 ppm tolerance) and tulathromycin residues (for which no tolerance is established) in its edible tissues, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the ranch was found to hold animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under 21 U.S.C. § 342(a)(4). A key deficiency noted was the failure to maintain complete treatment records. Additionally, the firm adulterated new animal drugs, cephapirin sodium and cephapirin benzathine, by using them in an extralabel manner not directed by their approved labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), making the drugs unsafe and adulterated. Gonsalves Ranch must promptly correct these violations and implement preventative procedures, responding to the FDA within fifteen working days with a detailed plan and documentation to avoid potential regulatory actions like seizure or injunction.