FDA WARNING_LETTER - Te Velde Holsteins, LLC - March 20, 2014

The FDA conducted an investigation of Te Velde Holsteins, LLC's dairy and heifer raising operation in Johnstown, Colorado, from March 10-20, 2014. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm offered for sale an adulterated dairy cow for slaughter on August 30, 2013. Tissue samples from this animal showed desfuroylceftiofur residues at 3.48 ppm in kidney tissue and flunixin residues at 0.549 ppm in liver tissue, both significantly exceeding the established FDA tolerances of 0.4 ppm and 0.125 ppm, respectively (21 C.F.R. 556.113, 21 C.F.R. 556.286). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which is adulteration under section 402(a)(4) of the FD&C Act. A key deficiency noted was the failure to maintain treatment records for medicated animals. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. The firm must provide a written response within fifteen working days detailing corrective steps, prevention measures, and supporting documentation. Failure to comply could lead to further regulatory actions, including seizure or injunction.