FDA WARNING_LETTER - Terry Pominville - May 08, 2014

The FDA conducted an investigation of Pominville's Farm in April and May 2014, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issue involved the sale of an adulterated dairy cow for slaughter, which contained unsafe residues of cefazolin in its kidney, a drug for which FDA has no established tolerance in cattle, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the farm was found to hold animals under insanitary conditions, lacking a systematic review of treatment records and a control system for drug administration, increasing the likelihood of medicated animals with harmful residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Additionally, the human drug Cefazolin for Injection, USP, was adulterated through improper extralabel use. Specifically, the extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)), resulted in illegal residues (21 C.F.R. 530.11(c)), and involved a drug (cefazolin) prohibited for extralabel use in cattle (21 C.F.R. 530.41(a)(13)(iii)). These actions caused the drug to be unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). Pominville's Farm is responsible for correcting these violations promptly and establishing preventative procedures. Failure to comply may lead to regulatory actions like seizure or injunction. A written response detailing corrective actions and timelines is required within fifteen working days.