FDA Halts Sybaritic Sales Of Unapproved Devices

Law360, New York (January 11, 2010, 4:50 PM EST) -- Medical device maker Sybaritic Inc. has agreed to halt the production of certain products that have not received U.S. Food and Drug Administration approval until the company can comply with FDA quality standards.

Judge John R. Tunheim of the U.S. District Court for the District of Minnesota approved the parties’ consent decree of permanent injunction on Jan. 5, resolving the FDA’s suit accusing Sybaritic and three of its executives of manufacturing unapproved medical devices that lack appropriate FDA clearance review and approval for safety and effectiveness,...
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