Permanent Injunction against Pharmaceutical Innovations Sought by FDA Due to Manufacturing ViolationsOct 6, 2014
The U.S. Food and Drug Administration (FDA) is looking to place a permanent injunction on Pharmaceutical Innovations, Inc. and its principal officer Gilbert Buchalter. According to a press release issued by the agency on October 3rd, the FDA wants the company to stop “manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.” Pharmaceutical Innovations manufactures products used for diagnostic purposes in a health care setting, such as ultrasound, mammography, electrocardiogram gels and scanning pads.
The U.S. Department of Justice filed the complaint for permanent injection on behalf of the FDA on October 2, 2014 in the U.S. District Court for the District of New Jersey.
The company's manufacturing practices violate the current good manufacturing practice requirements of the Federal Food, Drug and Cosmetic Act, the FDA alleges. The agency says that Pharmaceutical Innovations distributed their product throughout the country without undergoing the mandatory premarket approval, which is necessary to determine that products are safe and effective.
“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 the FDA’s associate commissioner for regulatory affairs Melinda K. Plaisier. “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.”
In April 2012, U.S. marshals acting on behalf of the FDA seized certain lots of Other Sonic Generic Ultrasound Transmission Gel after FDA laboratories discovered significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca. These bacteria present a serious risk of infection, such as pneumonia. According to the FDA, some patients who underwent a surgical procedure involving Other Sonic Generic Ultrasound Transmission Gel at a Michigan hospital were infected with Pseudomonas aeruginosa. The agency urged health care professionals and facilities to stop using the product in a safety alert issued on April 18, 2012.