Federal regulators are working to shut down a medical device company that
produced ultrasound, mammography, and electrocardiogram gels that have
been tied to at least 16 infections.
Working with the Department of Justice, the U.S. Food and Drug Administration
(FDA) is seeking a permanent injunction against Pharmaceutical Innovations
Inc. and its principal officer, Gilbert Buchalter. The court order will
prohibit them from manufacturing, marketing, selling, and distributing
medical products until they come into compliance with all applicable FDA
According to the
FDA’s complaint, its inspections at Pharmaceutical Innovations’ New Jersey facility
identified numerous and repeated deviations from the manufacturing practices
required under the Federal Food, Drug, and Cosmetic Act. The company also
allegedly failed to obtain required FDA approval or clearance for several
new ultrasound gels it has brought into the market.
Most concerning, a Michigan hospital reported that it had traced infections
among 16 surgical patients to a specific gel made by Pharmaceutical Innovations.
However, the company failed to notify the FDA after becoming aware of
these infections, as required by law. Subsequent FDA testing on gel samples
revealed significant amounts of Pseudomonas aeruginosa and Klebsiella
oxytoca. The bacteria pose serious risks of infection, such as pneumonia.
“Patients should be able to have confidence that the health-care
products they use are safe,” U.S. Attorney Paul Fishman said in
a statement. “Actions like the one we are taking here reinforce
the law that manufacturers adhere to strict approval and production requirements.
We are committed to stopping those who don’t.”