FDA Takes Action Against Florida Medicated Animal Feed Manufacturer
The United States District Court for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Syfrett Feed Company Inc.
—On May 4, 2017, the United States District Court for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Syfrett Feed Company Inc. of Okeechobee, Florida; its owner and President Charles B. Syfrett I; Vice President Melissa S. Montes De Oca; and Operations Manager Charles B. Syfrett II. The consent decree requires the company to adequately control its production of medicated animal feeds and to comply with federal law before it can resume its medicated feed operations.
Over the course of three inspections of the company’s facility in January 2014, June 2015 and June 2016, the U.S. Food and Drug Administration documented multiple violations of the current good manufacturing practice (cGMP) regulations for medicated feeds.
During the course of these three inspections, FDA inspectors found Syfrett Feed failed to: establish and maintain adequate procedures for the identification, storage and inventory control of drugs intended for use in medicated feeds; establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds; and ensure that correct labels are used for all manufactured medicated feeds. Following the January 2014 inspection, the FDA issued a warning letter to Syfrett Feed in July 2014, citing the cGMP violations.
In 2014, Syfrett Feed informed the FDA that the company had received complaints relating to its horse pellet product and the subsequent euthanasia of 17 horses. The company has since agreed to discontinue the production of the horse feed connected to this incident.
“It is the responsibility of feed manufacturers to have sufficient manufacturing controls in place to ensure the safety of their products,” said Steven Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine. “The FDA will take whatever steps are necessary to protect animal health when we find repeated violations that raise safety concerns.”
The consent decree prohibits Syfrett Feed from processing, manufacturing, preparing, packing and distributing the medicated animal feed it produces until the defendants hire an expert to ensure that they are following all cGMP regulations in the manufacture of medicated feed and until the FDA provides Syfrett Feed with written permission that they may resume the manufacture and distribution of their medicated feed.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.