FDA WARNING_LETTER - Double Tree Dairy Farm, LLC - September 23, 2016

On September 21 and 23, 2016, the FDA investigated Double Tree Dairy Farm, LLC, finding violations of the FD&C Act. A dairy cow sold for slaughter on April 6, 2016, was found to have 5.25 ppm of desfuroylceftiofur in kidney tissue, exceeding the 0.4 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically inadequate record-keeping for medicated animals. Treatment records lacked dosage, route of administration, meat/milk withdrawal times, and administrator's identity, making it likely that animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug (b)(4) (ceftiofur) was adulterated because it was used extralabelly without veterinary supervision and resulted in an illegal drug residue. The farm admitted to selling a cow three days before its 13-day withdrawal period for (b)(4) was met, violating 21 CFR 530.11(a) and (d), and rendering the drug unsafe and adulterated under 21 U.S.C. § 360b