FDA WARNING_LETTER - Samuel A. Fisher Farm - July 29, 2013

On July 23 and 29, 2013, the FDA investigated Samuel A. Fisher Farm in Myerstown, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a culled dairy cow for slaughter on October 12, 2012, which was found to have sulfadimethoxine in its liver tissue at (b)(4) ppm, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, 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).

Furthermore, the new animal drug Albon (sulfadimethoxine, 15g bolus, NADA #031-715) was adulterated because it was used extralabelly without following the withdrawal period and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (d). The Albon used also had an expired date of December 2008. This extralabel use caused the drug to be unsafe and adulterated under 21 U.