After submitting a guilty plea for two misdemeanor counts of introducing adulterated medical devices into interstate commerce, Pharmaceutical Innovations will pay a criminal fine of $50,000 and will also forfeit an additional $50,000 representing the approximate value of the products in question, according to the article. In addition, the company will receive two years of probation.
The company also agreed to settle a civil case related to the matter. As part of the settlement, Pharmaceutical Innovations agreed to destroy gel products that tested with high levels of infectious bacteria, and also agreed to an injunction. Independent experts and auditors will be conducting regular inspections and certifications at the company's expense, according to the story.
The firm's gel was tied to a 2011 outbreak of Pseudomonas aeruginosa infection at Beaumont Health System in Michigan. Sixteen patients were infected after receiving transesophageal ultrasound procedures during cardiovascular surgery, which led the U.S. Food and Drug Administration (FDA) to issue a warning in 2012 about the gel's risk of infection.
FDA laboratories had found Pseudomonas aeruginosa and Klebsiella oxytoca during testing of several lots of the firm's gel. In 2014, the FDA sought a permanent injunction to ban Pharmaceutical Innovations and its CEO from manufacturing or selling products until they complied with FDA requirements.
In a statement published by NJ.com, Pharmaceutical Innovations President Charles Buchalter said the day marked a "major milestone in Pharmaceutical Innovations' ongoing efforts to enhance its manufacturing processes in support of a new start for our company and our next generation of products. We are pleased to have addressed the concerns of the FDA and to demonstrate our continuing commitment to manufacturing high-quality products for our customers in compliance with all applicable regulations."
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