FDA WARNING_LETTER - Bednarek Brothers - July 14, 2011

On July 13-14, 2011, the FDA inspected Bednarek Brothers dairy farm in Stetsonville, WI, and found violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated bob veal calf for slaughter on November 30, 2010. USDA/FSIS analysis of tissue samples from this calf revealed tilmicosin at 40.868 ppm in liver and 4.616 ppm in muscle, exceeding the 1.2 ppm and 0.1 ppm tolerances for cattle, respectively, which do not apply to veal calves. Flunixin was found at 0.19 ppm in liver, exceeding the 0.125 ppm tolerance for cattle liver, and tulathromycin was present in kidney, for which no tolerance exists in veal calves.

These drug residues caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Additionally, the firm held animals under insanitary conditions, failing to maintain complete treatment records and lacking an animal identification system to ensure withdrawal times were observed, leading to adulteration under section 402(a)(4). Bednarek Brothers must take prompt action to correct these violations and prevent recurrence. A written response detailing corrective steps and timelines is required within fifteen working days to Dr. Brian D. Garthwaite. Failure