Terumo Cardiovascular Cited for GMP Violations by the FDA

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The federal government and Terumo Cardiovascular Systems (CVS) have come to terms on a consent degree issued by the U.S. Food and Drug Administration (FDA). The move bars the company from selling medical devices used in heart surgery, following years of quality control problems at company facilities at its U.S. base in Ann Arbor, Michigan. The agreement will be subject to the approval of the United States District Court for the Eastern District of Michigan. Terumo will be prohibited from manufacturing and distributing two of its heart-lung bypass systems and other cardiovascular devices to new customers after the FDA found that the company did not take corrective and preventive action to fix problems cited in earlier inspections.

Terumo CVS, a division of Tokyo-based Terumo, Corp., agreed to pay $35 million in back profits from the sale of its devices.

Last March, FDA inspectors reported more than a dozen quality control violations at the company’s plant in Ann Arbor. The company was cited for similar problems and received warning letters in 2004 and 2006 about its potential violations to the good manufacturing practice. During the FDA inspection that took place between January and March 2010, the agency found violations including nonconforming products, complaints, purchasing, process validation, design controls and adverse event reporting.

Under the terms of the agreement, Terumo will create a work plan to resolve the observations. Until the work plan is complete, Terumo agrees to restrict the distribution of certain products manufactured at the plant to existing customers who deem the products medically necessary. Products manufactured at the plant include heart-lung machines and cannulae, as well as other related products used in cardiac surgery.

Other Terumo products are not impacted by the decision, including: oxygenators, perfusion circuits that don’t contain cannulae, and all other products produced at the company’s other manufacturing facilities in Elkton, Md., and Ashland, Mass.; and products distributed by Terumo that are manufactured by other suppliers.

The consent decree does not involve any other Terumo division, company officials said.

“Terumo CVS is committed to fully addressing all of the FDA’s concerns. Over the past year, Terumo CVS had already begun implementing a significant quality system initiative that will create systemic, sustainable improvements in its Quality Systems,” said Mark Sutter, president and CEO of Terumo Cardiovascular Systems. “Terumo CVS has always been, and will remain, committed to those in the cardiac surgery community who use our products. Our ultimate goal during the consent decree is minimizing the inconvenience or disruption to our customers.”

The FDA said the decree will restrict Terumo from distributing and manufacturing the following products:

• Terumo Advanced Perfusion System 1;
• Sarns Modular Perfusion System 8000;
• Sarns Centrifugal System;
• HX2 Temperature Management System;
• Sarns TCMII Cooling and Heating System;
• CDI 500 Blood Parameter Monitoring System;
• Sarns Sternal Saw II System and Replacement Blades;
• T-Link Data Management Systems (Software Upgrades);
• Cannulae for cardiopulmonary bypass;
• Cannulae for cardioplegia delivery; and
• Vents, suckers, dilators, connectors and reducers.

In addition, Terumo must cease the distribution of its CDI 101 Hematocrit/Oxygen Saturation Monitoring System, which has not yet been reviewed by the FDA.

Because no devices are under recall, the products will continue their places within the current market and Terumo will continue to provide service, replacement parts and loaner devices to its existing customers.