FDA WARNING_LETTER - Papas Dairy, LLC - October 19, 2007

An FDA inspection of Papas Dairy, LLC, conducted October 17-19, 2007, revealed multiple violations. A cow consigned for slaughter on September 11, 2007, was found to have sulfadimethoxine residues of 0.60 ppm in liver and 0.41 ppm in muscle, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The dairy lacks an adequate system to ensure medicated animals are withheld from slaughter for appropriate withdrawal periods, evidenced by incomplete treatment records. This causes food from such animals to be adulterated under 21 U.S.C. § 342(a)(4).

Furthermore, the dairy engaged in illegal extralabel drug use of ALBON® (sulfadimethoxine) boluses and penicillin G procaine. ALBON® was administered without following approved dosage levels and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a), and resulted in illegal residues, violating 21 C.F.R. 530.11(d). IBA Penicillin G Procaine Injectable Suspension was administered without following approved dosage, route, or duration, and without veterinarian supervision, violating 21 C.F.R. 53