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The agency found that the material used to stopper bottles under vacuum and for lyophilization of soft tissue was not tested for microorganisms. Read More
A medical device manufacturer in Yokneam, Israel failed to submit adverse event reports to the FDA within 30 days after becoming aware of numerous complaints that warranted them, the agency said. Read More
The FDA flagged two overseas facilities for inadequate medical device reporting and improper handling of nonconforming products, and cited a Florida devicemaker for numerous issues observed in a July inspection. Read More
Royal Philips agreed to enter into a consent decree with the U.S. Department of Justice to suspend production of its automated external defibrillators at two of its U.S. manufacturing sites. Read More
The FDA flagged device firms in the U.S., France, Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other GMP issues. Read More
Euro-Diagnostics, Kelyniam Global, Magellan Diagnostics and Pelvic Therapies drew warning letters from the FDA for a range of GMP and other failures. Read More