Syfrett Feed Company Inc. of Okeechobee, FL, along with its owner and president, vice president and operations manager were named Thursday in a consent decree of permanent injunction by the U.S. District Court for the Southern District of Florida.
The injunction permanently enjoins the defendants from distributing misbranded and adulterated medicated animal feed in violation of the federal Food, Drug, and Cosmetic Act, and requires the defendants to cease manufacturing medicated animal feed until remedial steps are taken. Named in the injunction with the company are owner and president Charles B. Syfrett I, vice president Melissa S. Montes De Oca and operations manager Charles B. Syfrett II.
According to the complaint filed by the Food and Drug Administration, the company’s medicated animal feeds failed to list the name of the active drug ingredients and to include adequate instruction for use on the labels. As noted in the complaint, the label of the medicated feeds did not include dose administration instructions, feeding limitations and/or cautionary statements for use of the drugs in combination with other drugs.
The complaint also alleged that the medicated feed was not manufactured in conformity with current good manufacturing practices for medicated feeds. For example, the complaint alleged that the defendants failed to establish and maintain adequate procedures for the identification, storage, and inventory control of drugs intended for use in their medicated feeds, and failed to establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of animal feeds.
“Animal feed manufacturers that fail to comply with labeling and good manufacturing requirements for medicated animal feeds jeopardize the health of animals,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division.
“The Department of Justice and FDA will continue to work together to ensure that animal feed manufacturers produce safe medicated animal feed products.”
The complaint further alleged that Syfrett Feed conducted a recall of its non-medicated horse pellet food in April 2014 when customers complained that their horses were falling ill after consuming it. The complaint stated that 15 horses had to be euthanized, and in September 2014, two more horses had to be euthanized after consuming Syfrett Feed’s horse pellet food. According to the complaint, following these events, Syfrett Feed discontinued manufacturing medicated and non-medicated feeds for horses.
The complaint was originally filed Feb.1 by the DOJ at FDA’s request. The consent decree entered Thursday resolves that litigation.
The decree requires that the defendants adhere to the law’s labeling requirements and current good manufacturing practices for medicated animal feeds. The decree also directs Syfrett Feed to cease manufacturing medical animal feed until the company implements specified remedial measures. The measures include, among other things, retaining an expert to conduct an inspection of Syfrett Feed and certifying that the company’s manufacturing methods, facilities and controls are in conformity with current good manufacturing practices for medicated feeds.
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