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.
