The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.
The Newark, N.J.-based company’s products include ultrasound, mammography and electrocardiogram gels, and scanning pads. These products are medical devices used for diagnostic purposes in healthcare settings.
The complaint alleges that the defendants did not manufacture their devices in conformity with the current good manufacturing practice requirements of the Federal Food, Drug, and Cosmetic Act, and that they distributed their products nationwide without required premarket approval or clearance.
The complaint also details that U.S. marshals, acting at the request of the FDA, seized certain lots of Other-Sonic Generic Ultrasound Transmission Gel from the company in April 2012. The seizure took place after FDA laboratories found in those lots significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca—bacteria that pose serious risks of infection, such as pneumonia, to people exposed to the product.
The FDA is aware of people who were infected with Pseudomonas aeruginosa after having undergone a surgical procedure 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, the 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 by the U.S. Department of Justice on behalf of the FDA on Oct. 2.