FDA WARNING_LETTER - Baroun Farms - October 09, 2015

On September 18 and October 9, 2015, the FDA inspected Baroun Farms, a replacement heifer operation in Whitelaw, Wisconsin, owned by Mike T. and Shirley A. Baroun. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on June 29, 2015, Baroun Farms sold a heifer for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal identified desfuroylceftiofur at 1.85 ppm in the kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 CFR 556.113). This violates section 402(a)(2)(C)(ii) of the FD&C Act, deeming the food adulterated due to unsafe new animal drug residues.

Furthermore, the investigation found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Baroun Farms failed to maintain treatment records for medicated animals and did not keep a drug inventory, violating section 402(a)(4) of the FD&C Act.

Baroun 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