FDA WARNING_LETTER - Sunny Boys Dairy - November 05, 2014

On November 3-5, 2014, the FDA inspected Sunny Boys Dairy in Delta, Utah, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated the new animal drug (b)(4) (sterile Penicillin G Procaine, injectable suspension, (b)(4)) by using it extralabelly. Specifically, the drug was administered to a culled dairy cow, back tag (b)(4), without following the recommended dose and route of administration, and for treating Mastitis, a condition not identified in the approved product labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and rendering the drug unsafe under section 512(a) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) [21 U.S.C. § 351(a)(5)]. The FDA requires prompt corrective action to prevent recurrence, with a written response due within fifteen working days detailing steps taken or planned. Failure to comply may result in regulatory actions like seizure or injunction.