FDA WARNING_LETTER - Millenkamp Cattle - September 04, 2009

On September 2 and 4, 2009, the FDA inspected a calf-raising operation in Jerome, Idaho, and found violations of the Federal Food, Drug, and Cosmetic Act. A calf sold for slaughter on April 29, 2009, was found to have 0.28 ppm of penicillin residue in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The operation also failed to maintain complete treatment records for the calf, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, the new animal drug PenOne Pro Penicillin G Procaine Injection (NADA 65-010) was used extralabelly without following approved labeling for indications, dosing, and duration, and without the supervision of a licensed veterinarian, violating 21 C.F.R. Part 530. This caused the drug to be unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5).

The FDA requires prompt corrective action within fifteen working days, including