FDA WARNING_LETTER - Cledale - September 06, 2013

The FDA conducted an investigation of CLEDALE's dairy operation on August 28 and September 6, 2013, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary issue involved the sale of a bob veal calf for slaughter, whose kidney tissue contained 9.64 ppm of neomycin, exceeding the 7.2 ppm tolerance and having no acceptable level for veal calves. This rendered the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the firm held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4), exemplified by a failure to maintain complete treatment records. CLEDALE also adulterated the new animal drugs neomycin and oxytetracycline, contained in McNess - Acidified Stress Milk Replacer NT 1600 - Medicated, by using it extra-label. This extra-label use was not under licensed veterinarian supervision (21 C.F.R. 530.11(a)) and resulted in illegal residues (21 C.F.R. 530.11(c)), making the drugs unsafe (21 U.S.C. 360b(a)) and adulterated (21 U.S.C. 351(a)(5)). The medicated feed itself was also adulterated (21 U.S.C. § 351(a)(6)) and unsafe (21 U.S.C. § 360b) due to its extra-label use, which is prohibited for medicated feeds (21 C.F.R. 530.11(b)). The FDA requires prompt corrective actions and a written response within fifteen working days, detailing steps taken to correct violations and prevent recurrence. Failure to comply may lead to regulatory actions like seizure or injunction.