FDA WARNING_LETTER - Gutman Brothers, Ltd.

On August 8, 2012, the FDA inspected Gutman Brothers, Ltd.'s dairy operation in New Holland, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act. Two bob veal calves sold for slaughter were adulterated due to unsafe new animal drug residues.

Specifically, a calf sold on March 26, 2012, had sulfamethazine residues of 25.715 ppm in the liver and 18.979 ppm in muscle tissue. Another calf sold on April 2, 2012, had 21.797 ppm in the liver and 21.733 ppm in muscle tissue. These levels exceed the FDA tolerance of 0.1 ppm for sulfamethazine in cattle tissues (21 C.F.R. 556.670). Furthermore, FDA has no tolerance for Sustain III Calf Bolus (sulfamethazine) in calves under one month or on an all-milk diet (21 C.F.R. 520.2260b). This constitutes adulteration under 21 U.S.C. 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, failing to maintain treatment records, which may lead to harmful drug residues entering the food supply, violating 21 U.S.C.