FDA WARNING_LETTER - Pearson, Eric J. - October 21, 2014

An FDA inspection of Eric J. Pearson's veal calf operation in Springville, PA, in October 2014, identified multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm offered adulterated animals for slaughter, maintained insanitary conditions, and adulterated a new animal drug and medicated feed. Two bob veal calves sold in March and June 2014 contained illegal residues of penicillin (1.569 ppm) and neomycin (12.3 ppm and 33.98 ppm) in kidney tissue, exceeding tolerances and having no acceptable level for Neomycin Oral Solution in veal calves, thus adulterating the food (21 U.S.C. § 342(a)(2)(C)(ii)). The firm's failure to maintain treatment records led to inadequate conditions, risking medicated animals with harmful residues entering the food supply, constituting adulterated food (21 U.S.C. § 342(a)(4)). Furthermore, Neomycin Oral Solution, ANADA 200-379, was adulterated via extralabel use without licensed veterinarian supervision (21 C.F.R. 530.11(a)) and resulted in illegal residues (21 C.F.R. 530.11(c)), making the drug unsafe and adulterated (21 U.S.C. § 360b(a), § 351(a)(5)). Medicated feed (cow's milk with Neomycin Oral Solution) was also adulterated (21 U.S.C. § 351(a)(6)) by being fed to bob veal calves, as extralabel medicated feed use is prohibited (21 C.F.R. 530.11(b)). The FDA requires prompt corrective actions and a written response within fifteen working days, warning of potential seizure or injunction for non-compliance.