FDA Accuses Pharmaceutical Innovations of Non-compliance

Oct. 7, 2014

The U.S. FDA said in a press release 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 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 seized certain lots of Other-Sonic Generic Ultrasound Transmission Gel from the company in April 2012.

“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. Read the full release