FDA WARNING_LETTER - Millane Dairy

On December 18, 2012, the FDA investigated Millane Dairy in Greencastle, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated the new animal drug Agri-Cillin (Sterile Penicillin G Procaine Injectable Suspension) NADA 065-010 by using it extralabelly, specifically administering it to a dairy cow (ear tag (b)(4), back tag (b)(4)) without following the approved labeling's dosage, dosage per injection site, conditions for use, and withdrawal time. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and making the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Millane Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action like seizure or injunction. A written response detailing corrective actions must be submitted to the FDA within fifteen working days of receiving the letter.