FDA WARNING_LETTER - Zeinstra Farms, LLC - March 08, 2013

On February 12, 21, and March 8, 2013, the FDA investigated Zeinstra Farms, LLC, finding violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on October 30, 2012, was found to be adulterated, containing neomycin at 13.03 ppm (tolerance 7.2 ppm) and desfuroylceftiofur at 1.86 ppm (tolerance 0.4 ppm) in kidney tissue, exceeding established tolerances. This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the farm held animals under insanitary conditions, failing to maintain complete treatment records, which makes food from such animals adulterated under section 402(a)(4). The FDA also cited a violation of section 301(h) for providing a false guaranty on November 20, 2003, certifying that livestock sold would not have illegal drug residues, despite the October 30, 2012, sale of an animal with violative residues. Zeinstra Farms must take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction.