FDA WARNING_LETTER - Emanuel J. Lantz - April 16, 2013

The FDA conducted an inspection of Emanuel J. Lantz's dairy operation on April 10 and 16, 2013, resulting in a Warning Letter dated June 25, 2013. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm sold a bob veal calf for slaughter that was adulterated, as tissue samples contained flunixin residues, for which no tolerance exists in pre-ruminating calves, violating 21 U.S.C. 342(a)(2)(C)(ii). Additionally, animals were held under inadequate conditions, such as a failure to maintain treatment records and animal identification, 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). The firm also adulterated the new animal drug FluMeglumine (flunixin meglumine) through extralabel use. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c). The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. A written response detailing corrective steps and timelines must be submitted within fifteen working days. Failure to comply may lead to further regulatory actions, including seizure or injunction.