In a letter dated June 8, 2016, the FDA concludes: "Terumo is no longer enjoined under Paragraph 5 of the Consent Decree from manufacturing, packing, storing, installing, and/or distributing the above listed products from the Ann Arbor Facility." The letter followed the FDA's inspection of the facility in early May during which the agency found no inspectional observations.
The Ann Arbor manufacturing facility designs, produces, and distributes electromechanical devices used in cardiac surgery, such as heart-lung machines and blood parameter monitoring systems. The FDA considers some of these devices ‘life-sustaining,' a category of devices that requires a robust Quality Management System commensurate with these types of devices.
Terumo CVS agreed to the shipping restrictions in 2011 as a condition of its consent decree with the FDA. Under the terms of the consent decree, Terumo CVS would create and execute a work plan to address the FDA's concerns with the Quality Management System at the Ann Arbor facility. In addition, Terumo CVS would restrict distribution of products manufactured at the plant until the work plan was complete.
Terumo CVS completed the first phase of a two-phase work plan in December, 2014. After a subsequent inspection of the facility, the FDA determined in February, 2015 that Ann Arbor's general Quality Management System, as well as processes specific to its CDI® Blood Parameter Monitors, were in compliance with regulation and it lifted shipping restrictions on the monitors.
Terumo CVS completed the second and final phase of its work plan in February, 2016, leading to the FDA's inspection in May.
For additional information about the consent decree, see http://www.terumo-cvs.com/consentdecree
Terumo CVS will resume distribution of its monitoring systems this summer and expects to scale up production of its heart-lung machines after it completes several engineering projects to manage obsolescence issues.
"This means we have demonstrated to the FDA that we have the Quality System and infrastructure needed to manufacture life-sustaining devices in full compliance with the FDA regulation," says Mark Sutter, President and CEO, Terumo CVS. "But most importantly for all of our employees and our customers, it means that our Ann Arbor facility is now stronger and in a better position to serve our customers. We are looking forward to fulfilling our company's mission of helping save lives."
The consent decree did not impact the production or distribution of products manufactured at Terumo CVS' other factories, including oxygenators for which Terumo is a global market leader. Nor did it impact any other Terumo subsidiary or corporate entity.
About Terumo Cardiovascular Systems
Terumo CVS, part of Terumo Cardiovascular Group, is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiac and vascular specialties. It manufactures and markets or distributes medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring. The company is headquartered in Ann Arbor, Michigan, with US manufacturing operations in the Elkton, Maryland and Ashland, Massachusetts. For more information, visit www.terumo-cvgroup.com.
About Terumo Corporation
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with more than $4 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use and also supplies drug delivery/injection devices to pharmaceutical firms. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange and is a component of the Nikkei, Japan's leading stock index.
(Notice) Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts on projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. The market share information in this press release is partly derived from our own independent research.