FDA WARNING_LETTER - Vaqueria Ruben Gonzalez - June 15, 2012

The FDA conducted an inspection of Vaquería Rubén González's dairy operation on June 5, 8, and 15, 2012, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issues revolve around the extralabel use of the new animal drug Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil). Specifically, the firm administered the drug mixed in cow's colostrum to a bob veal calf, disregarding the labeled prohibition against using colostrum as food for 96 hours post-calving. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)), involved the drug in or on feed (21 C.F.R. 530.11(b)), and resulted in illegal drug residues (21 C.F.R. 530.11(d)). Additionally, the firm administered Quartermaster® to a dairy cow within six weeks of freshening, again without following approved labeling and without veterinary supervision. These actions caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. Furthermore, the dairy cow’s medicated colostrum was adulterated (section 501(a)(6)) and rendered unsafe (section 512) when fed to the calf. The FDA requires prompt corrective action, a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence, and warns of potential regulatory actions like seizure or injunction if compliance is not achieved.