FDA WARNING_LETTER - Brunner Farm - April 10, 2012

An FDA investigation conducted on April 3 and 10, 2012, at Brunner Farm in New Franken, Wisconsin, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of prescription veterinary drugs, including dinoprost tromethamine, dexamethasone, ceftiofur hydrochloride, and flunixin meglumine, without a lawful written or oral order from a licensed veterinarian. This practice renders the drugs misbranded under section 503(f)(1)(C) of the FD&C Act. Furthermore, these prescription drugs were deemed misbranded under section 502(f)(1) of the FD&C Act because they lacked adequate directions for use, as such directions cannot be provided for laypersons for prescription medications, per 21 CFR 201.5. The investigation also uncovered deficiencies in the farm's quality system, specifically the failure to maintain complete drug treatment records and the absence of an adequate drug inventory system. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Brunner Farm must notify the FDA in writing within fifteen working days, detailing all steps taken or planned for correction and prevention, including supporting documentation. Failure to comply may lead to further regulatory actions, such as seizure or injunction.