The FDA filed a complaint for permanent injunction against Pharmaceutical Innovations Inc. in the U.S. District Court for the District of New Jersey late last week. The agency is trying to get the company to stop manufacturing, marketing, selling and distributing its products until they comply with the FDA requirements.
The company is based in Newark, New Jersey and sells ultrasound, mammography and electrocardiogram gels. The FDA states that their products don't meet the current good manufacturing practice requirements of the Federal Food, Drug and Cosmetic Act and that they were selling their products around the world without premarket approval or FDA clearance.
In April 2012, the FDA instructed U.S. marshals to confiscate some of the company's Other-Sonic Generic Ultrasound Transmission gels after the FDA laboratories found out that they contained a significant amount of Pseudomonas aeruginosa and Klebsiella oxytoca, which are bacteria that can cause serious infections such as pneumonia.
Patients at a hospital in Michigan were infected with the bacteria after they underwent a procedure that used the company's gel. As a result, the FDA alerted health care facilities to refrain from using the gel because of the risks associated with it.
Gilbert Buchalter, president of the company, issued a statement at that time in which he explained that they instructed all of the distributors of the affected gels to suspend distribution and return them to his company. He wrote that he believes that the actions that his company took were sufficient.
He added that it was the only incident in the history of his company related to its sterile or non-sterile products since it opened its doors in 1961.
But more than two years later the problem still persists. "Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law," Melinda K. Plaisier, the FDA's associate commissioner for regulatory affairs, said in a statement. "This presents serious health risks to patients who used and continue to use the company's products."
