FDA WARNING_LETTER - Red Arrow Dairy, LLC - June 04, 2008

On October 22, 2008, the FDA issued a Warning Letter to Red Arrow Dairy, LLC, following an investigation from May 23 to June 4, 2008, at their Hartford, Michigan, dairy operation. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, Red Arrow Dairy sold an adulterated bob veal calf on December 11, 2007, which was slaughtered on December 13, 2007. Tissue analysis by USDA/FSIS found 0.13 ppm of penicillin in the kidney and 0.151 ppm of flunixin in the liver. FDA has not established tolerances for these drugs in veal, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. Although Red Arrow Dairy stated the calf was intended to be raised as a steer, they failed to notify the purchaser it should not be slaughtered for food.

Furthermore, the FDA found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4) of the Act. A key deficiency was the failure to maintain adequate drug treatment records for medicated animals.

This is not the first instance of illegal residues; on May 4, 2007, a dairy cow sold by Red Arrow Dairy