FDA WARNING_LETTER - Avis Dairy - September 10, 2012

On September 4 and 10, 2012, the FDA inspected Avis Dairy in Elk Grove, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs, specifically Penicillin G Procaine Injectable Suspension, Flunixin Meglumine, Oxytetracycline Injection, and Sulfadimethoxine Injection, by using them extralabelly without following approved labeling directions.

The extralabel use of Penicillin G Procaine Injectable Suspension, Flunixin Meglumine, and Oxytetracycline Injection was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Additionally, Sulfadimethoxine Injection was routinely administered to lactating dairy cows without following the route of administration, which is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9). These actions caused the drugs to be unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

Avis Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. A written response detailing corrective actions and timelines is required within fifteen working days of receiving the letter.