Silveira Ranches – FDA Warning Letter, Aug 17, 2011

On August 9, 11, and 17, 2011, the FDA investigated Silveira Ranches' dairy operation in Novato, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed the adulteration of new animal drugs: sulfadimethoxine, penicillin G procaine, florfenicol, cephapirin sodium, and neomycin-penicillin G procaine Mastitis Tubes. These drugs were used in an extralabel manner, not as directed by their approved labeling, which is only permissible under specific conditions outlined in 21 CFR Part 530.

Specifically, sulfadimethoxine was administered to a lactating dairy cow (ear tag (b)(4)) at an incorrect dosage, an extralabel use prohibited in lactating dairy cattle per 21 CFR 530.41(a)(9). Penicillin G procaine was given to a dairy cow (ear tag (b)(4)) at an incorrect dosage without licensed veterinary supervision, violating 21 CFR 530.11(a). Florfenicol was administered to replacement calves more frequently than prescribed by a veterinarian, also without licensed veterinary supervision, violating 21 CFR 530.11(a). Cephapirin sodium was given to a dairy cow (ear tag (b)(4)) without following consecutive treatment directions and without licensed veterinary supervision, violating 2