FDA Seeks Injunction Against Maker of Radiology Gels that Distributed Products without Approval

FDA Seeks Injunction Against Maker of Radiology Gels that Distributed Products without Approval
October 6, 2014

After three years of noncompliance, the U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pharmaceutical Innovations.

According to the FDA's complaint, the company did not manufacture their devices in conformity with current good manufacturing practice requirements of the Federal Food, Drug and Cosmetic Act and that they distributed their products nationwide without premarket approval or clearance.

The 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 injunction would bar the company from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.

In 2012 U.S. Marshals seized certain lots of Other-Sonic Generic Ultrasound Transmission Gel because FDA lab staff found significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca – bacteria that pose serious risks of infection, such as pneumonia. 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 Plaisier, the FDA's associate commissioner for regulatory affairs.