FDA WARNING_LETTER - Hide A Way Dairy - April 15, 2011

The FDA conducted an inspection of Hide A Way Dairy, owned by Mr. Robert J. Vander Dussen, in Portales, New Mexico, from April 11-15, 2011. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, primarily concerning the offering of adulterated animals for slaughter. A key finding was that a dairy cow consigned on January 24, 2011, contained Sulfadimethoxine residues in its liver (0.311 ppm) and muscle (0.384 ppm), significantly exceeding the FDA tolerance of 0.1 ppm (21 CFR 556.640). This rendered the animal's tissues adulterated under section 402(a)(2)(C)(ii) of the Act. Furthermore, the FDA found that the dairy held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under section 402(a)(4). Specific deficiencies included a failure to maintain an adequate system for ensuring proper drug withdrawal times before slaughter and a failure to maintain and review complete treatment records for medicated animals. The firm's response to the FDA 483 was deemed inadequate due to a lack of documentation for corrective actions. The FDA emphasized the need for prompt corrective action and establishment of preventative procedures, warning of potential regulatory actions like seizure or injunction if compliance is not achieved. The letter also noted previous USDA/FSIS notifications regarding illegal drug residues in animals from the dairy in 2004, 2008, and 2010, highlighting a history of non-compliance. A written response detailing corrective actions is required within fifteen working days.