FDA Takes Action Against New Jersey Manufacturer
The agency is seeking a permanent injunction, and its complaint states that FDA is aware of people who were infected with Pseudomonas aeruginosa after surgical procedures at a Michigan hospital involving one of the company's products.
The U.S. Food and Drug Administration announced Oct. 3 that it is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they comply with all applicable FDA requirements. The company is located in Newark, N.J., and makes ultrasound, mammography, and electrocardiogram gels and scanning pads, which are classified as medical devices used for diagnostic purposes in health care settings.
FDA's complaint alleges they did not manufacture their devices as required by the Federal Food, Drug, and Cosmetic Act and distributed their products nationwide without the required premarket approval or clearance.
The agency's complaint states that U.S. marshals seized some lots of Other-Sonic Generic Ultrasound Transmission Gel from the company in April 2012 after FDA laboratories found in those lots significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca, which are bacteria that pose serious risks of infection, such as pneumonia, and that FDA is aware of people who were infected with Pseudomonas aeruginosa after surgical procedures at a Michigan hospital involving Other Sonic Generic Ultrasound Transmission Gel. On April 18, 2012, FDA issued a safety alert to health care professionals and facilities to stop using the contaminated product.
“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,” said Melinda K. Plaisier, FDA’s associate commissioner for regulatory affairs. “This presents serious health risks to patients who used and continue to use the company's products. By taking this action, the FDA is demonstrating its commitment to protecting the public from the dangers of adulterated and misbranded medical products.”
The complaint for permanent injunction was filed Oct. 2, 2014, in a federal court in New Jersey.