FDA WARNING_LETTER - John and Nicole Santos Dairy - October 16, 2012

On October 10, 11, 12, and 16, 2012, the FDA investigated John and Nicole Santos Dairy in Turlock, California, identifying violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The dairy offered for sale adulterated animals for slaughter.

Specifically, a bob veal calf sold on July 5, 2012, contained sulfamethoxazole at 1.551 ppm in liver and 2.898 ppm in muscle. Another bob veal calf sold on July 16, 2012, had sulfamethoxazole at 2.71 ppm in liver and 10.124 ppm in muscle. FDA has no established tolerance for sulfamethoxazole in veal, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the dairy engaged in extralabel drug use of sulfamethoxazole/trimethoprim, penicillin G procaine, oxytetracycline, ceftiofur, and pirlimycin without veterinary supervision, violating 21 C.F.