BALTIMORE, Md. — The US Food and Drug Administration (FDA) has sent a warning letter to rendering company Valley Proteins, Inc. for “significant violations of the Federal Food, Drug and Cosmetic Act” found during an inspection at its Winchester, Virginia facility.
The agency found Valley Proteins’ finished rendered fat product for animal food production to contain pentobarbital in a sample taken on Nov. 14, 2018 and issued a Form 483 to address the issue. Additionally, the agency conducted inspections of the Winchester, Virginia facility on Feb. 5 and 6, and Apr. 3 and Apr. 22, 2019.
According to the FDA, Valley Proteins “failed to adequately address this problem” after the rendering company stated that “pentobarbital is an ‘unavoidable contaminant not known to present a health hazard,’” which contradicts the agency’s understanding of the drug.
Pentobarbital is an approved drug used to anesthetize or euthanize certain animals.
The agency also stated the rendering company failed to identify hazards among its raw materials, “which included carcasses of animals euthanized with pentobarbital.” Valley Proteins had not listed pentobarbital as a known or reasonably foreseeable hazard for its operations, according to the agency.
The FDA said the company should have understood that pentobarbital is a risk as many of its raw animal-based ingredients are obtained from animals that were likely to have been euthanized using chemicals.
The agency continues to work with Valley Proteins to adequately clean the facility to get rid of traces of pentobarbital and to set up accountability standards for potentially adulterated product that was distributed. Valley Proteins did not issue a recall for products found to include pentobarbital.
The FDA also commented that the rendering company was not sufficiently labeling its finished products that may not be processed to control microbial hazards, as well as not adequately implementing other food safety parameters.
Valley Proteins has submitted a revised food safety plan to document to its suppliers and the FDA that it will no longer accept “dead stock,” or euthanized animals, for processing but will continue to collect and dispose of those carcasses. The agency asked the rendering company to further clarify how it would identify and segregate euthanized animals to ensure they are not processed for animal food.
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