Manuel and Maria Silva Dairy – FDA Warning Letter, Nov 29, 2013

On November 25, 26, and 29, 2013, the FDA inspected Manuel and Maria Silva Dairy in Stockton, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs, specifically Dexamethasone Solution, Ceftiofur Sodium, Flunixin Injection, Oxytetracycline, Penicillin Injectable, and Enrofloxacin.

The investigation revealed extralabel use of these drugs, meaning they were not used as directed by their prescription labels or approved labeling, violating 21 C.F.R. 530.3(a). The extralabel use of Dexamethasone, Ceftiofur Sodium, Flunixin, Oxytetracycline, Penicillin G Procaine, and Enrofloxacin was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Notably, Ceftiofur Sodium is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13).

Specific instances included administering Dexamethasone without following the veterinarian's prescribed conditions and dosage; Ceftiofur Sodium to a bob veal calf and lactating dairy cows without adhering to conditions, dosage, or withdrawal times; Flunixin to a bob veal calf, lactating dairy cows, and heifers without