FDA WARNING_LETTER - Reuben R. Zimmerman - September 17, 2014

The FDA issued a Warning Letter to Rueben R. Zimmerman following an inspection of his dairy operation on September 15 and 17, 2014. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act related to animal drug use and food adulteration. Specifically, the firm offered for sale a dairy cow for slaughter as food that was adulterated, containing penicillin and flunixin residues exceeding established tolerances (21 U.S.C. 342(a)(2)(C)(ii)). The firm was also found to hold animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulterated food under 21 U.S.C. 342(a)(4), exemplified by a failure to maintain complete treatment records. Furthermore, the firm adulterated new animal drugs, Penicillin Injectable and Ceftiofur, through extralabel use not directed by approved labeling or veterinary prescription (21 U.S.C. 351(a)(5)). Specific extralabel use violations included administering penicillin without licensed veterinarian supervision (21 C.F.R. 530.11(a)) and resulting in illegal drug residue (21 C.F.R. 530.11(d)). Ceftiofur was also used extralabelly without licensed veterinarian supervision (21 C.F.R. 530.11(a)), with certain uses being prohibited by 21 C.F.R. 530.41(a)(13)(ii). The FDA requires prompt corrective action, including establishing procedures to prevent recurrence. A written response detailing corrective steps, timelines, and documentation is due within 15 working days. Failure to comply may lead to regulatory actions like seizure or injunction.