A consent decree of permanent injunction between the US Food and Drug Administration (FDA) and the Florida-based feed company was made last week, according to case documents. The ruling called for the company to cease making medicated feed until it is able to control the production of its medicated animal feeds and is in compliance with federal law. It continues to make other types of animal feed.
The ruling came from Judge Robin Rosenberg with the US District Court for the Southern District of Florida.
The FDA inspected the company’s facility three times from January 2014 through June of 2016 and reportedly found multiple violations of established current good manufacturing practice (cGMP), said the FDA.
“It is the responsibility of feed manufacturers to have sufficient manufacturing controls in place to ensure the safety of their products,” said Steven Solomon, 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 complaint was filed by the US Department of Justice for the FDA. The FDA is responsible for the safety, effectiveness and security of public health and for several products, including food, and the use of human and veterinary drugs.
“We are glad this case is resolved and look forward to FDA’s inspection and having this matter behind us,” Melissa Syfrett, company president, told FeedNavigator. “We remain committed to high quality and safe feeds for our customers.”
Findings and decree provisions
Multiple site visits reportedly found that Syfrett Feed had failed to set and maintain adequate procedures for the identification, storage and inventory control of the drugs intended for use in the medicated feeds, said the FDA.
The company also had 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,” the agency added.
And it was not certain that the correct labels were used for all the medicated feeds manufactured, the agency said.
The consent decree requires Syfrett Feed from “from processing, manufacturing, preparing, packing and distributing” medicated animal feed that it has generated until it meets several provisions, said the FDA.
To regain the ability to make and distribute medicated animal feed, it has to hire an expert to verify that the company is following all cGMP regulations during the manufacture of medicated feed, the agency said. And, the FDA has to provide written permission for them to restart that production.
The company also has to tell the FDA the steps take to address the issues found, said the judge in the decree. And, all inspections, reviews and examinations done by the FDA have to be paid for by Syfrett.
However, the company can move and deliver medicated feed make somewhere else by an unaffiliated feed mill, as long as that product is not further process or relabeled by the company, the judge said.
Additionally, the company has to post the decree at company facilities, provide it to members or employees with the company and verify that it has done so, said the judge. The FDA also will have to be notified of any change in ownership or renaming of the company.
In five years, the company can apply for measures to be lifted, the judge said in the decree. “If Defendants have maintained, to FDA’s satisfaction, a state of compliance with this Decree, the Act, and all applicable regulations for five (5) years preceding Defendant’s petition, the United States will not oppose such petition,” the judge added.
Warning letter details
In a warning letter sent in July 2014, an inspection was done by the FDA and the Florida Department of Agriculture after the company applied or a medicated feed license, said the FDA. However, it identified several violations of the Federal Food and Drug Act.
A warning letter was issues in July of 2014 referencing the cGMP violations, said the FDA. Also that year, the company told the agency that is had heard complaints about a pelleted product for horses and the euthanasia of 17 horses.
The site inspection found that there alleged was a lack of adequate procedures for the identification and control of inventory, including to maintain the “strength, quality and purity” of type A and type B medicated products, the agency said. Buildings also were maintained in a way that allowed access by vermin and pests.
“Our investigators established that you were using the new animal drugs chlortetracycline and fenbendazole in combination in cattle feed in your Deseret Range Cubes Med. w/Safeguard product (Batch Run Serial #28031), contrary to the New Animal Drug Application (NADA) approvals for these drugs,” the agency said. “Also, our investigators established that the new animal drugs, chlortetracycline, amprolium, and salinomycin were being used in combination in a finished poultry feed in your Syfrett Garcia Chick Grower Med. Product (Batch Run Serial #30352), contrary to the NADA approvals for these drugs The animal feed containing the combination of these drugs in cattle and poultry feeds is unsafe.”
While the company did withdraw its request for a medicated feed license and responded to some of the initial violations found, more work and documentation were considered necessary, the agency said.