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FDA seeks permanent injunction against Pharmaceutical Innovations, Inc.

Oct 08, 2014 01:55PM ● By Cate Reynolds
Defendants charged with distributing adulterated and misbranded medical devices

For Immediate Release
October 3, 2014

The U.S. Food and Drug Administration 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 come into compliance with all applicable FDA requirements.

The Newark, New Jersey company’s products include ultrasound, mammography, and electrocardiogram gels, and scanning pads. These products are medical devices used for diagnostic purposes in health care 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, 2014, in the U.S. District Court for the District of New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.