FDA WARNING_LETTER - Bremer, William - January 03, 2014

On January 2-3, 2014, the FDA investigated William Bremer's dairy operations in Independence, Wisconsin, at his home farm and a rented farm. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on May 28, 2013, Bremer sold a dairy cow for slaughter that was found to have gentamicin in its kidney tissue by USDA/FSIS analysis. FDA has not established a tolerance for gentamicin residues in dairy cattle, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation found insanitary conditions, including a failure to maintain treatment records and a lack of an adequate drug inventory system, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Additionally, Bremer was found to have mixed gentamicin and Penicillin G Potassium to create an infusion for a dairy cow, which is not in accordance with approved labeling or a lawful veterinary order.

Bremer is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines must be submitted to the FDA within 15 working days of receiving the letter. Failure to comply may result in regulatory actions such as seizure and/or injunction.