FDA WARNING_LETTER - Nunes Brothers Dairy - August 01, 2012

On July 30 and August 1, 2012, the FDA inspected Nunes Brothers Dairy in Wendell, Idaho, and found multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on April 24, 2012, was found to have 0.11 ppm of penicillin in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug Pro-Pen-G Injection (penicillin G procaine) was adulterated because it was used extralabelly without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and making the drug unsafe under 21 U.S.C. § 360b(a) and adulterated under 21 U.S.C. § 351(a)(5).

Additionally, the dairy provided a false BSE & Drug Residues Affidavit and Declaration on April 22,