FDA WARNING_LETTER - Sunset Dairy - August 24, 2012

On August 24, 2012, the FDA inspected Sunset Dairy, owned by Todd A. Benedict, in Bear Lake, PA, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on or about June 5, 2012. USDA/FSIS analysis of tissue samples from this animal, slaughtered on June 6, 2012, revealed Desfuroylceftiofur at 8.52 ppm in the kidney, exceeding the FDA tolerance of 0.4 ppm for Ceftiofur (21 C.F.R. 556.113). Additionally, Flunixin was found at 0.851 ppm in the kidney, surpassing the FDA tolerance of 125 ppb (21 CFR 556.286).

These drug residue levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)]. The investigation also revealed insanitary conditions, specifically the failure to maintain treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the Act [21 U.