FDA WARNING_LETTER - Thelen Livestock (Brad Thelen) - June 15, 2012

On April 6 and June 15, 2012, the FDA investigated Thelen Livestock in Long Prairie, Minnesota, and found violations of the Federal Food, Drug, and Cosmetic Act. A Charolais heifer sold for slaughter on December 22, 2011, was found to have penicillin at 0.96 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 CFR 556.510). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, specifically a lack of identification records for purchased and sold animals, and no treatment records for medicated animals. These conditions make it likely that medicated animals with harmful drug residues could enter the food supply, causing food to be adulterated under section 402(a)(4) of the Act.

The FDA requires prompt corrective action to prevent recurrence, including establishing procedures to ensure compliance. Failure to do so may result in regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines is required within 15 working days of receiving the letter.