(Reuters) - A spinal implant manufacturer and its chief executive have reached a $1 million settlement with the U.S. Food and Drug Administration for selling unapproved devices.
The settlement requires privately held Globus Medical Inc of Audubon, Pennsylvania, to pay a $550,000 penalty and David Paul, its CEO, to pay $450,000, FDA said in a statement.
During a September 2010 inspection, FDA investigators learned the company had marketed its NuBone Osteoinductive Bone Graft product without proper regulatory approval.
Globus had sought clearance for the product in January 2009, but FDA declined to approve it after determining that it was not substantially equivalent to legally marketed products. The company continued to distribute the product anyway.
Reporting By Susan Kelly; Editing by Steve Orlofsky