FDA WARNING_LETTER - Luis Dairy - August 16, 2013

On November 1, 2013, the FDA issued a Warning Letter to Luis Dairy following an investigation conducted on August 13, 14, and 16, 2013. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the extralabel use of new animal drugs.

The dairy adulterated several new animal drugs, including penicillin-dihydrostreptomycin, penicillin G procaine injectable suspension, oxytetracycline hydrochloride injection, Dexamethasone, and florfenicol. Specifically, the extralabel use of these drugs did not comply with 21 C.F.R. Part 530, which requires such use to be by or on the lawful order of a licensed veterinarian within a valid veterinarian/client/patient relationship.

Violations included: - Administering penicillin-dihydrostreptomycin to dairy cows, resulting in medicated colostrum, and allowing bob veal calves access to this colostrum without observing the 96-hour (eight milkings) prohibition for food use after calving. This constituted extralabel use in or on feed, violating 21 C.F.R. 530.11(b), rendering the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The medicated colostrum was