The civil complaint was filed in the US District Court for the Southern District of Florida against Syfrett Feed Company Inc, its owner, Charles B Syfrett I, its vice president, Melissa Montes De Oca, and its operations manager, Charles B Syfrett II, to “stop the adulteration and misbranding of medicated animal feed.”
The complaint, which the US Department of Justice filed on behalf of the FDA, alleged Syfrett’s failed to list the name of the active drug ingredients on the label of medicated feeds and failed to include adequate instructions for use on those labels.
Syfrettt manufactures, on average, 69,000 tons of feed annually using 176 different formulas. Around 70% of the company’s feeds are medicated.
In addition to livestock feeds, Syfrett Feed also warehouses and distributes bagged pet food, according to the filing.
Lack of conformity with CGMP alleged
The plaintiff argued 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 claimed Syfrett Feed did not manufacture the feed in conformity with current good manufacturing practices (CGMP) for medicated feeds.
Specifically, noted the filing, the defendants failed to set up and maintain adequate procedures for the identification, storage, and inventory control of drugs intended for use in its medicated feeds.
The plaintiff alleged Syfrett Feed also failed to establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds.
“[The] defendants are aware of their ongoing violations of the Act,” noted the court papers.
The court documents also mention the rationale behind the enforcement action: “Based on [the] defendants’ conduct, [the] plaintiff believes that, unless restrained by order of this court, [the] defendants will continue to violate 21 U.S.C. § 331(k) by adulterating and misbranding its medicated feed.”
In April 2014, Syfrett Feed conducted a recall of its non-medicated horse pellet food when customers complained that their horses were falling ill after consuming Syfrett Feed’s horse pellet food. Fifteen horses, subsequently, had to be euthanized, reported the legal document. “[The] defendants did not inform FDA of the recall until May 2015, nearly a year after the recall. In September 2014, two more horses had to be euthanized after consuming Syfrett Feed’s horse pellet food. Following these events, [the] defendants discontinued manufacturing medicated and non-medicated feeds for horses,” noted the complaint.
FDA inspections
The FDA conducted inspections of Syfrett Feed’s facility in Okeechobee, Florida in January 2014, June 2015 and June 2016, with the agency reporting it had observed significant CGMP deviations and misbranding violations during all three inspections.
In 2014, following the inspection, the FDA said it sent a warning letter to the owner, notifying him of the significant violations observed during that year’s inspection.
In September 2015, the agency said it again wrote to the owner, claiming Syfrett Feed had not taken adequate measures to correct the irregularities noted in the FDA 2014 warning letter and 2015 inspection.
Syfrett Feed reportedly did not respond to that FDA communication: “During FDA’s 2016 inspection, Ms Montes De Oca confirmed that she received the September 11, 2015 letter but decided not to respond,” according to the complaint.
The company, though, repeatedly promised the federal agency to undertake the corrections. However, at each inspection, the FDA has found that defendants have either failed to implement them or have done so inadequately, claimed the plaintiff.
Steven Solomon, director of the FDA’s Center for Veterinary Medicine, commented on the case: “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.”
Acting assistant attorney general, Chad Readler, head of the US Justice Department’s civil division, reacted to the complaint: "The FD&C Act is designed to make sure that medicated animal feed has sufficient labeling to ensure its safe use." He added that his department would work closely with the FDA to ensure that medicated feeds are manufactured in compliance with CGMP.