FDA WARNING_LETTER - Jerald and Janine Stewart Farm - June 09, 2017

On June 28, 2017, the FDA issued a Warning Letter to Jerald and Janine Stewart Farm following an investigation conducted on June 6, 8-9, 2017, at their beef cow-calf operation in Newcastle, Nebraska. The investigation found that the farm offered an adulterated animal for slaughter as food, violating sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, a cow slaughtered on March 1, 2017, contained drug residues exceeding established tolerances: Flunixin at 10.2 ppm in the liver (tolerance 0.125 ppm), Desfuroylceftiofur at 10.395 ppm in the kidney (tolerance 0.4 ppm), and Oxytetracycline at 23.0 ppm in the kidney (tolerance 12 ppm). These levels render the food adulterated.

Furthermore, the farm failed to maintain treatment records, indicating insanitary conditions where medicated animals with harmful drug residues are likely to enter the food supply, also constituting adulteration. The FDA requires prompt corrective action to prevent recurrence, including a written response within fifteen working days detailing steps taken or planned. Failure to comply may result in regulatory actions such as seizure or injunction.