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.
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.
(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.