In a move that avoided a complete recall of its products, Union, N.J.-based Shelhigh today agreed to a court order that bans the cardiac and neurosurgery devicemaker from continued distribution of its implantable devices until the company brings its production processes in line with Food and Drug Administration standards, according to an FDA news release.
The injunction, issued by the U.S. District Court in New Jersey, ended a two-month stalemate that began in April when the FDA, citing violation of sterilization procedures, seized up to 1 million products and components from the device manufacturers plant. Though the FDA requested a voluntary recall of Shelhigh devices in May, the company has refused to do so.
Under todays agreement, Shelhigh will discontinue distribution of all devices until its manufacturing methods, facilities, and controls are in compliance with (the) FDAs current good manufacturing practices, according to the FDA news release. Shelhigh officials will hire independent consultants to inspect its Union, N.J., facility and certify compliance with FDA standards. The FDA also will monitor the facility corrections and conduct its own inspections. -- by Shawn Rhea