Regarding the Result of Inspection at Terumo CVS Ann Arbor Plant
Tokyo — Terumo Corporation (TSE: 4543 Section 1) announced today the result of the inspection conducted by the FDA at the Ann Arbor plant of its U.S. subsidiary, Terumo Cardiovascular Systems (hereafter Terumo CVS).
In March 2011, Terumo CVS agreed on the terms of a consent decree with the FDA regarding improvements to the quality system at the Ann Arbor plant. Since then, the company has completed an FDA-approved work plan. The FDA then inspected the plant in January 2015 and had no inspectional observations. Based on the result, the FDA notified Terumo CVS that the quality system in the Ann Arbor plant is in compliance with FDA regulations, and that all injunctive restrictions are lifted for hardware components of its intraoperative monitoring system, allowing the company to resume the manufacturing and supply of the product within fiscal year 2015.
Another product manufactured at the plant, the heart-lung machine, was not subject to the recent inspection, as it will require additional time to acquire validation data for the large number of production parts and processes. The company expects an investment of 1.5 billion yen this fiscal year to complete its activities.
Terumo Corporation will leverage the knowledge and experience from establishing the new quality system at the Ann Arbor plant to 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. Terumo’s Ashitaka plant in Japan (Shizuoka) 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.