FDA WARNING_LETTER - Larry Bourdeau / Windy Acres Farm - April 07, 2011

The FDA issued a Warning Letter to Larry Bourdeau/Windy Acres Farm following an inspection on April 4 and 7, 2011, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary concern was the sale of adulterated bob veal calves for slaughter. Tissue samples from two calves revealed illegal residues of desfuroylceftiofur (exceeding established tolerances of 0.4 ppm in kidney and 1 ppm in muscle) and flunixin (for which no tolerance exists in veal calves). This rendered the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the farm was found to hold animals under insanitary conditions, specifically failing to maintain complete treatment records and lacking an adequate drug inventory system, increasing the likelihood of medicated animals with harmful residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). The new animal drugs Excenel RTU (ceftiofur hydrochloride) and Banamine (flunixin meglumine) were also deemed adulterated due to their extralabel use, not as directed in approved labeling and not under the supervision of a licensed veterinarian (21 C.F.R. § 530.11(a)). This extralabel use also resulted in illegal drug residues for both ceftiofur hydrochloride (21 C.F.R. § 530.11(d)) and flunixin meglumine (21 C.F.R. § 530.11(c)), causing the drugs to be unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). The firm's April 18, 2011, response was inadequate, lacking proof of implemented corrective actions. The FDA requires prompt correction, written notification within 15 working days, and warns of potential regulatory actions like seizure or injunction if compliance is not achieved.