James T. Blue & Sons, Inc. – FDA Warning Letter, Jul 3, 2013

On September 5, 2013, the FDA issued a Warning Letter to James T. Blue & Sons, Inc. following an investigation conducted on May 28, June 3, and July 3, 2013. The investigation confirmed the sale of an adulterated bob veal calf for slaughter on or about February 27, 2013. USDA/FSIS analysis of tissue samples from this animal, slaughtered on February 28, 2013, revealed Neomycin at 43.01 ppm in kidney tissue, exceeding the established tolerance of 7.2 ppm. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act.

Furthermore, the investigation found that the operation holds animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. Specifically, the firm lacks an adequate system to ensure appropriate drug withdrawal periods, failing to maintain treatment records and control drug administration. This renders food from such animals adulterated under section 402(a)(4) of the Act.

The FDA requires prompt corrective action to address these violations and prevent recurrence. The firm must respond in writing within fifteen working days, detailing steps taken or planned, including documentation. Failure to comply may result in regulatory actions such as seizure or injunction.