District Court Enters Permanent Injunction Against Florida Company and Senior Managers to Stop the Distribution of Misbranded and Adulterated Medicated Animal Feeds
The U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against Syfrett Feed Company Inc. of Okeechobee, Florida, its owner and President Charles B. Syfrett I, its Vice President Melissa S. Montes De Oca and its Operations Manager Charles B. Syfrett II, the Department of Justice announced today. 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.
The Department filed a complaint in the U.S. District Court for the Southern District of Florida on Feb. 1, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, 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 of the medicated feeds. 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 Syfrett Feed’s horse pellet food. 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 consent decree entered today resolves the 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.
This matter was handled by Trial Attorney Jocelyn Hines of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Christopher Cheek of the U.S. Attorney’s Office for the Southern District of Florida, with the assistance of Associate Chief Counsel for Enforcement Tara Boland of the FDA’s Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit its website at https://www.justice.gov/usao-sdfl.