FDA WARNING_LETTER - Son-D-Farms Inc - September 16, 2011

On September 14 and 16, 2011, the FDA inspected Son-D-Farms Inc.'s swine operation in Adrian, Minnesota, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated sow for slaughter, which contained penicillin residues (0.68 ppm in kidney) exceeding the zero tolerance (21 CFR 556.510), a violation of 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also revealed that animals were held under inadequate conditions, such as failing to segregate treated animals and maintain complete treatment records, increasing the likelihood of medicated animals with harmful residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, the firm engaged in extralabel use of penicillin G procaine injectable suspension, administering an incorrect dosage (2 cc per 100 pounds instead of 1 mL per 100 pounds) without a prescription or a valid veterinary-client-patient relationship. This constituted a violation of 21 CFR 530.11(a) and resulted in illegal drug residues, violating 21 CFR 530.11(d). Consequently, the drug itself was deemed unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5). Son-D-Farms Inc. is required to take prompt corrective actions within 15 working days, detailing steps to prevent recurrence, or face potential regulatory actions like seizure or injunction.