FDA WARNING_LETTER - Parisville Dairy, LLC - November 13, 2013

The FDA investigated Parisville Dairy, LLC in November 2013, uncovering multiple violations of the Federal Food, Drug, and Cosmetic Act. A key finding was the sale of an adulterated dairy cow for slaughter, containing illegal residues of desfuroylceftiofur (7.55 ppm vs. 0.4 ppm tolerance) and flunixin (3.31 ppm vs. 0.125 ppm tolerance in liver), violating 21 U.S.C. 342(a)(2)(C)(ii). The firm also held animals under insanitary conditions, including poor treatment record-keeping and expired drugs, increasing the risk of contaminated food and constituting adulteration under 21 U.S.C. 342(a)(4). Furthermore, new animal drugs (Excede, Prevail) were adulterated due to extralabel use not supervised by a licensed veterinarian (21 C.F.R. 530.11(a)) and resulting in illegal drug residues (21 C.F.R. 530.11(d)), violating 21 U.S.C. 351(a)(5). A false guaranty regarding drug residues in livestock was also provided, prohibited by 21 U.S.C. 331(h). While Parisville Dairy responded with proposed changes to record-keeping and drug management, an animal was still released prematurely. The FDA mandates prompt corrective actions and preventative procedures, requiring a written response within fifteen working days detailing all steps and documentation. Non-compliance could lead to regulatory actions such as seizure or injunction.