FDA WARNING_LETTER - Leland Bruce Shaw - April 12, 2011

On March 31, April 4, and April 12, 2011, the FDA investigated Leland Bruce Shaw's dairy farm in Clayton, NY, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf transported on December 13, 2010, and slaughtered on December 14, 2010, was found to be adulterated. USDA/FSIS analysis of tissue samples from the calf identified flunixin in the liver at 0.0926 ppm, for which FDA has not established a tolerance in veal calves. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

Additionally, the farm holds animals under insanitary conditions, lacking an adequate system to ensure medicated animals are withheld from slaughter for appropriate periods, leading to potentially harmful drug residues entering the food supply. Specifically, incomplete treatment records were noted. This renders food adulterated under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

The FDA requires prompt corrective action to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines must be submitted within fifteen working days to Patricia