FDA WARNING_LETTER - Smucker, Samuel - October 14, 2014

The FDA conducted an investigation of Samuel J. Smucker's dairy farm in Narvon, Pennsylvania, on October 8, 10, and 14, 2014, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale two bob veal calves for slaughter as food that were adulterated, containing neomycin residues (15.4 ppm and 12.3 ppm) in kidney tissue, exceeding the 7.2 ppm tolerance and having no acceptable level for veal calves when using NT Concentrate. This constitutes adulterated food under 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, the investigation revealed animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, exemplified by a failure to maintain treatment records, violating 21 U.S.C. § 342(a)(4). The firm also adulterated the new animal drug NT Concentrate (Neomycin Sulfate/Oxytetracycline) through extralabel use, administering it to a class of animal not specified in its approved labeling and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and resulting in illegal drug residues, violating 21 C.F.R. 530.11(c). This rendered the drug unsafe and adulterated under 21 U.S.C. § 351(a)(5). Additionally, the animal feed was adulterated by adding NT Concentrate to milk replacer, a prohibited extralabel use under 21 U.S.C. § 351(a)(6). The FDA requires prompt corrective actions and a written response within 15 working days detailing steps taken to prevent recurrence, or face potential regulatory action like seizure or injunction.