FDA WARNING_LETTER - Schneider Dairy - November 03, 2014

On October 1 and November 3, 2014, the FDA investigated Schneider Dairy, LLC, located in Westphalia, Michigan, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated culled dairy cow for slaughter on February 4, 2014. USDA/FSIS analysis of tissue samples from this animal (ear tag # (b)(4), back tag # (b)(4)) revealed 4.64 ppm of desfuroylceftiofur in the kidney tissue, exceeding the FDA tolerance of 0.4 ppm for ceftiofur residues in cattle kidneys (21 C.F.R. 556.113). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that Schneider Dairy holds animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Specifically, the dairy failed to maintain complete treatment records, lacking details such as the route of administration and required withdrawal times. An invoice from the veterinary clinic, the only record for Cow # (b)(4) being medicated on February 1, 2014, lacked this crucial information. This constitutes adulteration under section 402(a)(4) of the FD&C Act.