FDA WARNING_LETTER - Kronebusch Farms, Inc. - January 25, 2013

On January 15-16 and 24-25, 2013, the FDA investigated Kronebusch Farms, Inc., a dairy operation in Altura, Minnesota. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on August 7, 2012, Kronebusch Farms sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 8, 2012, identified 0.47 ppm of penicillin in the kidney. This exceeds the FDA tolerance of 0.05 ppm for penicillin residues in uncooked edible cattle tissues (21 CFR 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation revealed that animals were held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. A specific deficiency noted was the failure to maintain complete treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Kronebusch Farms is required to take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure and/or injunction. A written response detailing corrective actions and timelines must be submitted to the