FDA WARNING_LETTER - Gallman Farms, LLC - June 04, 2015

On June 2-4, 2015, the FDA conducted an investigation of Gallman Farms, LLC, a swine raising operation in Mendon, OH, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of a sow for slaughter on March 25, 2015, which was found to have penicillin residues in its kidney tissue. This presence of penicillin, for which FDA has not established a tolerance (21 CFR § 556.510), caused the food to be adulterated under section 402(a)(2)(C)(ii) of the Act. Additionally, the investigation revealed that the firm holds animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. These conditions, exemplified by the failure to maintain treatment records, identify treated animals, and segregate them, render food adulterated under section 402(a)(4) of the Act. The firm's response to the FDA-483 was deemed inadequate as it lacked specific examples of corrective actions. Gallman Farms is required to take prompt action to correct these violations and establish procedures to prevent recurrence, notifying the FDA in writing within fifteen working days with details and documentation of corrective steps.