FDA WARNING_LETTER - A&M; De Sousa Dairy - March 17, 2012

On March 9, 12, and 17, 2012, the FDA investigated A&M De Sousa Dairy in Turlock, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs, specifically Penicillin G Procaine Injectable Suspension, Ceftiofur, Sulfamethazine, and Oxytetracycline Hydrochloride Injection, by using them extralabelly without following approved labeling directions.

The extralabel use of these drugs was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Specifically, Penicillin G Procaine Injectable Suspension was administered without following indications, dose, and dosage per injection site. Ceftiofur was administered to a lactating dairy cow (ear tag # (b)(4)) without following dosage per injection site, resulting in an illegal drug residue (21 C.F.R. 530.11(d)). Sulfamethazine was administered to a lactating dairy cow (ear tag # (b)(4)) and routinely to other lactating dairy cows without following animal class, dose, and frequency, which is prohibited for extralabel use in lactating dairy cattle (21 C.F.R. 530.41(a)(9)) and resulted in an illegal drug residue (21 C.F.R.