FDA WARNING_LETTER - Falls View Farm - November 15, 2013

The FDA conducted an investigation of Falls View Farm, owned by Mr. Matthew A. Surawski, on October 2, 24, and November 15, 2013, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale two bob veal calves for slaughter as food that were adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, due to illegal Neomycin residues (9.02 ppm and 14.91 ppm in kidney) exceeding the established tolerance or having no acceptable level for bob veal. The investigation also revealed that the farm held animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulteration under section 402(a)(4). Specific deficiencies included a failure to maintain treatment records for calves and the absence of a system to control drug administration. Furthermore, the firm adulterated new animal drugs, specifically Neomycin Sulfate and Oxytetracycline Hydrochloride in (b)(4), by not using the medicated supplement as directed by its labeling. This constituted extralabel drug use, violating 21 C.F.R. 530.11(a) by feeding it to an unapproved class of animals, and 21 C.F.R. 530.11(c) by resulting in illegal residues. This also led to adulteration under section 501(a)(6) of the FD&C Act. Falls View Farm must take prompt action to correct these violations and implement procedures to prevent recurrence. A written response detailing corrective actions, timelines, and supporting documentation is required within fifteen working days to FDA's New York District Office. Failure to comply may lead to regulatory actions such as seizure or injunction.