FDA Seeks Injunction Against Pharmaceutical Innovations Inc.

By Chuck Seegert, Ph.D.

The FDA recently filed allegations that Pharmaceutical Innovations Inc. failed to follow current good manufacturing practices (cGMP) and is distributing products without proper clearance.

cGMPs are a formal system of controls that must be put in place by every medical device manufacturer that wishes to sell products regulated by the FDA. The term encompasses a variety of activities like proper design, monitoring systems, validated manufacturing processes, and more. All of these requirements are in place to ensure that the product released by a company meets a quality standard that is safe and effective for patients. Failure to maintain these controls can lead to mix-ups and even the contamination of products that need to be sterile or aseptic.

A complaint for permanent injunction against Pharmaceutical Innovations 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, according to a recent press release from the agency. The company, based in Newark, New Jersey, makes medical device products that are used for medical diagnostics, like ultrasound and mammography gels.

In April 2012, U.S. marshals acting at the FDA’s request, seized certain lots of the company’s products. Quantities of the company’s Other-Sonic Generic Ultrasound Transmission Gel contained dangerous levels of the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca, according to the press release. Cases of infection with Pseudomonas aeruginosa were discovered after certain patients had undergone procedures with the gel, and soon thereafter the FDA issued a safety alert to users in the field, urging them to stop using the 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, in the press release. “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.”

Failure to comply with cGMPs can lead to significant risks to patients and end users of medical devices. The seriousness of these types of allegations is highlighted in the pharmaceutical space where civil and criminal charges are being brought against companies that violate the law.