![]() ![]() ![]() ![]() The FDA issued two warning letters to Tokyo, Japan-based Terumo, once in 2004 and once in 2006, about its potential violations to the good manufacturing practice. District Court for the Eastern District of Michigan, and under the document terms, Terumo will be prohibited from manufacturing and distributing two of its heart-lung bypass systems and other CV devices to new customers after FDA found that the company did not take corrective and preventive action. The Department of Justice (DoJ) will soon file the decree with the U.S. On March 17, Terumo executive officers signed a consent decree of permanent injunction and under its terms, Terumo will pay almost $35 million in profits from past sales to the federal government. During an inspection last year at Terumo Cardiovascular Systems’ Ann Arbor, Mich., plant, FDA officials found numerous violations to good manufacturing practice and medical device reporting requirements.
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