FDA WARNING_LETTER - Van Es Dairy - December 09, 2010

The FDA conducted an investigation of Mr. Van Es's dairy operation in Marsing, Idaho, on December 8 and 9, 2010, revealing significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter on June 16, 2010. Tissue samples from this animal showed flunixin residues in the liver at 0.662 ppm, exceeding the established tolerance of 0.125 ppm (21 C.F.R. 556.286), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the investigation found that animals were held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, a violation of 21 U.S.C. § 342(a)(4). A specific deficiency noted was the failure to maintain complete treatment records. The firm also engaged in extralabel drug use of Albon (sulfadimethoxine) Boluses and Prevail (flunixin meglumine) Injectable, not as directed by their approved labeling. Specifically, Albon was used extralabelly in lactating dairy cattle, which is prohibited by 21 C.F.R. 530.41(a)(9). Additionally, Prevail was used extralabelly without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). These extralabel uses caused the drugs to be unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5). The FDA requires prompt corrective action and a written response within fifteen working days, detailing steps taken or planned to correct violations and prevent recurrence, including documentation. Failure to comply may lead to regulatory actions like seizure or injunction.