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April 24, 2014

Tokyo -- Terumo Corporation (TSE: 4543 Section 1) announced today the result of the inspection conducted by FDA this year at its U.S. subsidiary, Terumo Cardiovascular Systems' (hereinafter Terumo CVS) Ann Arbor plant.

In March 2011, Terumo CVS had agreed on the terms of a consent decree with FDA regarding improvements to the quality system at the Ann Arbor plant. Since then, the company has completed the agreed work plan. FDA then inspected the plant in February 2014.

Based on the observations from the inspection, FDA informed Terumo CVS that it would need to make some additional corrections. As a result, the restriction on distribution of products manufactured at the plant was not lifted as expected at the end of March 2014. Terumo CVS' Ann Arbor plant will address FDA's remaining concerns through consultation with the agency and expects another inspection within this fiscal year. The company expects an investment of 3 billion yen this fiscal year to complete its improvement activities.

Since the agreement of consent decree in March 2011, Terumo Corporation has given top priority to improve the quality system of the entire group. Over the past three years, 12 Terumo group plants have undergone standard inspections by FDA and received no significant observations.

Terumo Corporation will accelerate the completion of improvement activities at Terumo CVS' Ann Arbor plant and further improve the quality system of the entire group.

Reference

The Ann Arbor plant of Terumo Cardiovascular Systems Corporation, located in Michigan, U.S.A., produces hardware products including heart-lung machines and intraoperative monitoring systems for cardiac surgery. Ashitaka plant in Japan and Elkton plant in U.S.A. (Maryland), which produce disposable products that account for the majority of sales in Cardiovascular Business of Terumo group, remain unaffected by the activities related to the consent decree and continue to manufacture and distribute products with no change.

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

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 or 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.

 

Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice.