FDA WARNING_LETTER - Gary Manternach Farm - November 04, 2015

On November 2-4, 2015, the FDA inspected Gary Manternach Farm, a beef feedlot operation in Monticello, IA. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on July 31, 2015, a steer from the feedlot was offered for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 4, 2015, showed florfenicol residues of 5.73 ppm in liver tissue and 0.36 ppm in muscle tissue. These levels exceed the FDA tolerances of 3.7 ppm for liver and 0.3 ppm for muscle, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the investigation found that animals were held under insanitary conditions, specifically due to a failure to maintain treatment records. This condition makes it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating the food under section 402(a)(4) of the Act.

The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps, including documentation, is required within fifteen working days of receiving the letter.