FDA WARNING_LETTER - Ihm Farms - March 30, 2017

An FDA inspection of Ihm Farms in Barneveld, Wisconsin, conducted on March 15 and March 30, 2017, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation found that the firm held animals under inadequate conditions, making it likely that medicated animals with potentially harmful drug residues would enter the food supply, thus adulterating the food under section 402(a)(4) of the Act. A key deficiency was the failure to maintain complete treatment records, which lacked essential information such as dose, route of administration, estimated withholding time, diagnosis, and the person administering the drug. Additionally, the firm adulterated the new animal drug ceftiofur hydrochloride (NADA (b)(4)) by administering it in an extralabel manner to a dairy cow. This included not following the approved labeling or veterinary prescription for dosage per injection site, duration of treatment, and route of administration. Extralabel use of ceftiofur hydrochloride in food-producing animals is explicitly prohibited by 21 CFR 530.41(a)(13)(ii). Ihm Farms is required to take prompt action to correct these violations and establish procedures to prevent their recurrence. A written response detailing corrective actions and timelines must be submitted to the FDA within 15 working days, with failure to comply potentially leading to regulatory actions such as seizure or injunction.