Ronald Andio, DBA Patron Farms, LLC – FDA Warning Letter, Apr 30, 2012

On July 9, 2012, the FDA issued a Warning Letter to Ronald Andio, DBA Patron Farms, LLC, following an inspection conducted on April 03, 05, and 30, 2012. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act related to the sale of animals for slaughter. Specifically, the firm sold a bay thoroughbred gelding horse for food that was found to be adulterated due to the presence of phenylbutazone and clenbuterol residues in its tissues, for which no FDA tolerance exists in horses. This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the FDA found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, such as failing to inquire about the medication status of purchased animals. This practice renders food adulterated under section 402(a)(4). A third significant violation involved providing a false Equine Information Document (EID) certificate, where Mr. Andio admitted to signing the producer's name without verifying the animal's medication status, which is prohibited by section 301(h) of the FD&C Act. The letter mandates prompt corrective actions, including implementing systems to determine animal medication status and ensuring appropriate drug withdrawal periods or proper identification of medicated animals. The firm must respond in writing within fifteen working days, detailing corrective steps and prevention measures, with potential regulatory actions like seizure or injunction if non-compliance persists.