FDA WARNING_LETTER - Caldwell Animal Hospital - August 14, 2013

An FDA investigation conducted on August 12-14, 2013, at Caldwell Animal Hospital, identified significant violations related to the extralabel use of drugs in veterinary practice. The practice used the human drug, Gentak (gentamicin sulfate) Ophthalmic Ointment USP, 0.3%, extralabelly to treat an eye infection in a beef cow. This action rendered the drug unsafe and adulterated under Sections 512(a)(1) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, due to non-compliance with 21 CFR Part 530, which governs Extralabel Drug Use in Animals. Consequently, the treated animal was offered for sale for slaughter as food, making it adulterated under Section 402(a)(2)(C)(ii) of the Act. Specifically, the practice failed to comply with 21 CFR 530.20(a)(2)(ii) by not establishing an extended withdrawal period for edible products and with 21 CFR 530.20(a)(2)(iv) by not ensuring withdrawal timeframes were met to prevent illegal drug residues. The FDA requires prompt corrective action and a written response within 15 working days detailing steps taken to correct these violations and prevent recurrence, warning of potential regulatory actions like seizure or injunction if not addressed.