The Food and Drug Administration (FDA) announces that Custom Ultrasonics, Inc., (CUI) has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA’s Current Good Manufacturing Practice requirements of its Quality System (QS) regulation. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures. The consent decree was signed by Judge Timothy J. Savage and entered on January 25, 2007 in the U.S. District Court for the Eastern District of Pennsylvania.
