We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA flagged four firms for a range of violations including a failure to submit medical device reports to the agency for fatal adverse events. Read More
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