FDA WARNING_LETTER - North Florida Holsteins, LLC. - January 10, 2014

On January 7-10, 2014, the FDA inspected North Florida Holsteins, LLC, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering an adulterated animal for slaughter, specifically a dairy cow with desfuroylceftiofur (ceftiofur marker) residue at 1.77 ppm in kidney tissue, far exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The inspection also revealed that animals were held under insanitary conditions, including a failure to maintain complete treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. § 342(a)(4). Furthermore, the firm adulterated the new animal drug Excede by using it extralabelly without licensed veterinary supervision (21 C.F.R. 530.11(a)) and causing an illegal drug residue (21 C.F.R. 530.11(d)), making the drug unsafe and adulterated under 21 U.S.C. §§ 360b(a) and 351(a)(5). The firm's January 23, 2014, response to the FDA 483 mentioned retraining staff and plans for better record review and drug inventory control, but lacked verification for retraining. North Florida Holsteins must take prompt corrective action and respond within 15 working days, providing documentation, to avoid further regulatory action like seizure or injunction.