FDA WARNING_LETTER - John Mellott Farm - August 27, 2008

The FDA conducted an investigation of John Mellott Farm, a dairy operation, on August 26-27, 2008, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of a bob veal calf for slaughter that was adulterated. Tissue samples from the animal revealed 8.42 parts per million (ppm) of neomycin in the kidney, exceeding the established tolerance of 7.2 ppm (21 CFR 556.430(b)(1)). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act. Furthermore, the investigation revealed that animals were held under inadequate conditions, increasing the likelihood of medicated animals bearing harmful drug residues entering the food supply, which constitutes adulteration under section 402(a)(4) of the Act. A key deficiency contributing to this was the firm's failure to maintain treatment records. As a producer of food animals, John Mellott Farm is responsible for ensuring compliance. The FDA requires prompt corrective action and the establishment of procedures to prevent recurrence. A written response detailing these steps, including documentation, must be submitted within fifteen working days. Failure to comply may lead to further regulatory actions, such as seizure or injunction.