FDA WARNING_LETTER - Balmer Brothers - September 25, 2014

On September 23 and 25, 2014, the FDA inspected Balmer Brothers dairy farm in Manheim, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm offered two bob veal calves for slaughter as food that were adulterated.

Specifically, a calf sold on January 30, 2014, and slaughtered on January 31, 2014, had neomycin at 12.68 ppm in kidney tissue. Another calf sold on February 27, 2014, and slaughtered on February 28, 2014, had neomycin at 10.27 ppm in kidney tissue. The FDA tolerance for neomycin in cattle edible tissues is 7.2 ppm, but there is no acceptable level for veal calves when using (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer (Neomycin Sulfate/Oxytetracycline). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain treatment records, making food from such animals adulterated under section 402(a)(4). Furthermore, the farm engaged in extra-label use of (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer by administering it to a class of animal not specified