FDA WARNING_LETTER - Red River Valley Dairy - September 02, 2015

On August 25 and September 2, 2015, the FDA inspected River Valley Dairy, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on June 9, 2015, was found to have 16.34 ppm of neomycin in its kidney tissue, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves. This rendered the animal adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The dairy also held animals under insanitary conditions, leading to potential drug residues in the food supply, violating 21 U.S.C. § 342(a)(4). Deficiencies included failure to segregate animals, maintain treatment records, and adequately identify animals transported for sale.

Furthermore, the drug IBA Scour Treat 10g (neomycin sulfate and oxytetracycline hydrochloride) was used extralabelly without veterinary supervision, in violation of 21 CFR 530.11(a), and administered in feed, violating 21 CFR 530.11(b). This extralabel use resulted in an illegal residue, violating 21 CFR 530.11(c), and caused the drug to be unsafe and adulterated under 21 U.S.C.