Medical Device Manufacturer Under Consent Decree for Selling Contaminated Product

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Medical Device Manufacturer Under Consent Decree for Selling Contaminated Product

Pharmaceutical Innovations, Inc. has pleaded guilty to criminal charges stemming from distribution of ultrasound gel that was contaminated with bacteria in an article from Justice News. This ultrasound gel is commonly used for ultrasounds, sonographs, EKGs and other procedures.

The company received two misdemeanor counts of introducing an adulterated medical device to interstate commerce. They will receive 2 years of probation and must pay a fine of $50,000 in addition to any civil action taken against them. The company had to throw out about $50,000 worth of product as well.

Pharmaceutical Innovations had to destroy gel products that tested high for infectious bacteria as ordered by the court and had to agree to having regular inspections done by auditors and independent experts to prevent this from happening again to any other medical device.

Since the gel is widely used for routine procedures in a setting with individuals with compromised immune systems, there was an urgency by the Department of Justice to have the product recalled. In 2012, 16 surgical patients were infected with Pseudomonas aeruginosa, a bacterial pathogen, from this particular gel.

Post-production tests of the gel yielded positives for Pseudomonas aeruginosa and Klebsiella oxytoca. These tests were conducted after the product had shipped and were performed by the same Michigan hospital that received a prior contaminated batch.

The civil complaint against Pharmaceutical Innovations was that the company was not approved or cleared by the Food and Drug Administration (FDA) to manufacture the gel and did not follow current Good Manufacturing Practices (cGMPs) during production. The company also failed to take required actions after reports of serious injuries came in.

Thus, Pharmaceutical Innovations must submit a detailed plan for compliance to the FDA within 20 days and must have outside experts certify that they are in compliance by October 31st. The FDA will conduct a follow-up inspection to verify that they are following cGMPs. This is all spelled out in the Consent Decree of Permanent Injunction by the Department of Justice.

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