The U.S. Department of Justice (DOJ) is moving to shut down Pharmaceutical Innovations, a Newark, N.J.-based company blamed for producing ultrasound gel that caused infections in 16 patients.
The DOJ, working on behalf of the Food and Drug Administration (FDA), filed a complaint against the company and its president and owner, Gilbert Buchalter, seeking an injunction to halt operations at the plant until it resolves violations to the Federal Food, Drug and Cosmetic Act. The DOJ claims the company produced the gel used in ultrasound tests without following proper manufacturing practices, failed to obtain proper approval before distributing its products, and failed to report to the FDA injuries associated with its products.
Pharmaceutical Innovations manufactures gels for ultrasound, mammography and electrocardiogram procedures, and makes scanning pads and sprays.
The complaint states that in February 2012, 16 patients at a Michigan hospital developed infections after being treated with a product made by Pharmaceutical Innovations. When the company became aware of the injuries, it failed to submit a report to the FDA. The agency discovered samples of the gel contained a significant amount of two different disease-causing bacteria – Pseudomonas aeguginosa and Klebsiella oxytoca.
The FDA conducted a series of investigations at the Newark facility after the infections were reported, and found that the company failed to routinely monitor its water system to ensure that the water was suitable for producing medical products, and that it does not routinely sanitize the tubing and connections of its water systems to ensure they do not contain any potentially harmful microorganisms. The company also didn’t comply with corrective action after the infections were reported.
The DOJ wants manufacturing and distributing operations at Pharmaceutical Innovations to stop until the company undergoes corrective action to comply with federal regulations to the satisfaction of the FDA.
Source: New Jersey Law Journal