The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Gel Maker Pleads Guilty to Criminal Charges for Contamination

Aug. 19, 2016

Pharmaceutical Innovations pleaded guilty to criminal and civil charges arising from its distribution of ultrasound gel contaminated with bacteria, according to the Department of Justice.

The Newark, N.J.-based company was charged with two misdemeanor counts of introducing adulterated medical devices into interstate commerce. The company was placed on probation for two years and ordered to pay a criminal fine of $50,000 and to forfeit an additional $50,000.

A related civil settlement was also resolved on July 6, under which the company agreed to destroy gel products that tested exceptionally high for infectious bacteria. The firm agreed to a consent decree of permanent injunction that requires independent auditors to conduct regular inspections at the company’s expense.

The charges link back to 2012 when a Michigan hospital reported 16 patients with bacterial infections believed to be associated with Pharmaceutical Innovations’ gel.

DOJ filed suit in October 2014 against the company and its founder and owner. The civil complaint alleged that the company was selling unapproved devices, and that it was violating GMP regulations.

The consent decree of permanent injunction requires the company to submit a detailed compliance plan to the FDA within 20 days.

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