The US Food and Drug Administration (FDA) has sued Pharmaceutical Innovations, a Newark-based maker and distributor of medical accessories and products, over an ultrasound gel that was not approved by the agency.
Working on behalf of the FDA, the US Department of Justice (DOJ) filed a complaint against the company and its principal officer Gilbert Buchalter, seeking a permanent injunction requiring operations at the plant to cease until it is brought into compliance with the federal regulations.
Products of Pharmaceutical Innovations’ include ultrasound, mammography and electrocardiogram gels, and scanning pads used for diagnostic purposes in health care settings.
According to the FDA, the company produced the gel used in ultrasound tests without complying with the current good manufacturing practice requirements of the Federal Food, Drug, and Cosmetic Act.
The company failed to secure proper premarket approval or clearance before distributing their products nationwide.
In February 2012, a Michigan hospital reported that it traced infections among 16 surgical patients to a specific gel made by Pharmaceutial Innovations.
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In April 2012, the US marshals seized certain lots of Other-Sonic Generic Ultrasound Transmission Gel from the company after FDA tests discovered the presence of significant amounts of ‘Pseudomonas aeruginosa and Klebsiella oxytoca’ bacteria, that pose serious risks of infection, such as pneumonia, to people exposed to the product.
FDA associate commissioner for regulatory affairs Melinda Plaisier said: "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.
"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."