FDA WARNING_LETTER - Ivy Farms, Inc. - January 28, 2013

On January 9, 11, and 28, 2013, the FDA inspected Ivy Farms, Inc. in Swanton, Vermont, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed the firm sold an adulterated bob veal calf containing illegal sulfamethoxazole residues (0.102 ppm in liver tissue), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Additionally, Ivy Farms held animals under inadequate conditions, including a failure to maintain treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). The FDA also found that Ivy Farms adulterated several new animal drugs through extralabel use not compliant with approved labeling or veterinary prescriptions, violating 21 C.F.R. Part 530. Specific instances included administering Sulfamethoxazole and Trimethoprim without following withdrawal periods, resulting in illegal residues (21 C.F.R. 530.11(c)), and without licensed veterinary supervision (21 C.F.R. 530.11(a)). Similar extralabel uses without veterinary supervision (21 C.F.R. 530.11(a)) were noted for Dexamethasone (not following indications), Florfenicol and Flunixin Meglumine (incorrect injection site), Penicillin G Procaine (not following indications), and Oxytetracycline Hydrochloride (not following indications and route of administration). These actions caused the drugs to be unsafe and adulterated under 21 U.S.C. §§ 360b(a) and 351(a)(5). Ivy Farms must take prompt corrective action and respond within fifteen working days, detailing steps to prevent recurrence, or face potential regulatory actions like seizure or injunction.