FDA WARNING_LETTER - David Montanez Calf Farm - January 21, 2010

An FDA inspection of David Montanez Calf Farm, conducted from January 19-21, 2010, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of adulterated animals for slaughter. Specifically, four calves sold on September 28, 2009, were found to contain Sulfamethazine residues in their edible tissues (liver and muscle) at levels exceeding the established tolerance of 0.1 ppm, with concentrations as high as 0.307 ppm. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act and 21 CFR 556.670. Additionally, the investigation determined that animals were held under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, which is a violation of section 402(a)(4) of the Act. Examples of these inadequate conditions included a failure to maintain records of purchased and sold animals and a failure to inquire about their medication status. The firm is required to take prompt corrective action, establish procedures to prevent recurrence, and notify the FDA within fifteen working days with a detailed plan and timeline. Failure to comply may lead to further regulatory actions, including seizure or injunction.