FDA WARNING_LETTER - Finnerty Dairy - August 08, 2017

On May 18 and August 8, 2017, the FDA investigated Finnerty Dairy, identifying violations of the Federal Food, Drug, and Cosmetic Act. A culled dairy cow sold for slaughter on September 12, 2016, was found to have sulfamethazine residues (0.157 ppm in muscle, 0.241 ppm in liver), exceeding the 0.1 ppm tolerance. The dairy administered Sustain III (sulfamethazine) to this cow, despite its labeling prohibiting use in lactating dairy cattle, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4). Deficiencies included incomplete drug treatment records (lacking condition treated, dosage, withdrawal times, route of administration), inadequate drug inventory systems (missing drug lists, quantities, lot/expiration dates), and failure to segregate treated animals from non-treated ones, with leg bands removed prematurely based on milk, not meat, withdrawal times.

Furthermore, the dairy engaged in extralabel use of Sustain III by administering it to lactating dairy cattle, which is prohibited for sulfonamide drugs under 21 C.F.R.