FDA WARNING_LETTER - Derrek Olson, LLC - October 03, 2016

On September 29 and October 3, 2016, the FDA inspected Derrek Olson, LLC's dairy operation in Plainview, Minnesota, and found significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter on February 11, 2016. USDA/FSIS analysis revealed flunixin residues at 0.632 ppm in the animal's liver, exceeding the FDA tolerance of 0.125 ppm (21 CFR 556.286), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also found that the firm held animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Specifically, the firm failed to document crucial information such as dosage, administration route, condition treated, frequency, and withdrawal times for medicated animals. Furthermore, the firm adulterated the new animal drug (b)(4) (flunixin meglumine injectable solution) through extralabel use. This use was not under the supervision of a licensed veterinarian, violating 21 CFR 530.11(a), and resulted in illegal drug residues, violating 21 CFR 530.11(d). This non-conforming use rendered the drug unsafe (21 U.S.C. § 360b(a)) and adulterated (21 U.S.C. § 351(a)(5)). The FDA requires prompt corrective action within 15 working days, including documentation of steps taken to prevent recurrence, to avoid further regulatory action like seizure or injunction.