A civil complaint was filed in the U.S. District Court for the Southern District of Florida against Syfrett Feed Company Inc. (Syfrett Feed) 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 to stop the adulteration and misbranding of medicated animal feed in violation of the federal Food, Drug, and Cosmetic Act (FDCA), the Department of Justice announced Wednesday, February 1.

Syfrett Feed Company Inc. (Syfrett Feed) manufactures and distributes medicated and non-medicated feed, primarily for food-producing animals and fowl. The complaint alleges that the defendants adulterated and misbranded animal feeds while such feeds were held for sale. The Department filed the complaint at the request of the U.S. Food and Drug Administration (FDA).

“The Food, Drug, and Cosmetic Act is designed to make sure that medicated animal feed has sufficient labeling to ensure its safe use,” said Acting Assistant Attorney General Chad A. Readler, head of the Justice Department’s Civil Division. “The Department of Justice will work closely with the FDA to ensure that medicated animal feeds are manufactured in compliance with current good manufacturing practices.”

According to the complaint, the company’s medicated animal feeds failed to list the name of the active drug ingredients on the label of the medicated animal feeds and failed to include adequate instructions for use on the labels of the medicated animal feeds. For example, as noted in the complaint, the defendants did not include adequate instructions when they omitted dose administration instructions, feeding limitations and/or cautionary statements for use of the drugs in combination with other drugs on the label of the medicated feeds.

The complaint further alleges that the feed was not manufactured in conformity with current good manufacturing practices for medicated feeds. Specifically, according to the complaint, 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; failed to 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 failed to adopt labeling practices that assure that the correct labels are used for the medicated feeds they manufacture.

As noted in the complaint, the company conducted a recall of its non-medicated horse pellet food in April 2014 when customers complained that their horses were falling ill. According to the complaint, 15 horses had to be euthanized after consuming the company’s horse pellet food and in September 2014, two more horses had to be euthanized after consuming the company’s horse pellet food. Following these events, the company discontinued manufacturing medicated and non-medicated feeds for horses, according to the complaint.

According to the complaint, FDA conducted inspections of Syfrett Feed’s facility located at 3079 NW 8th Street, Okeechobee, Florida, in January 2014, June 2015 and June 2016. In 2014, following the inspection, FDA sent a Warning Letter to Mr. Syfrett I, notifying him of the significant current good manufacturing practices deviations and misbranding violations observed during the January 2014 inspection. In September 2015, FDA wrote to Mr. Syfrett I, stating that Syfrett Feed had not taken adequate measures to correct the current good manufacturing practice deviations and misbranding violations noted in FDA’s 2014 Warning Letter and 2015 inspection. According to the complaint, Syfrett Feed did not respond to FDA’s September 2015 letter.

“Animal owners and caretakers must be able to have confidence that the feed they purchase is safe and properly labeled,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “It is the responsibility of feed manufacturers to have proper procedures in place and follow good manufacturing practices to ensure the safety of their products and the animals that consume them.”

The government is represented 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 F DA, Office of General Counsel, Department of Health and Human Services.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.