U.S. regulators have reached a civil settlement with a bone graft company, in which the CEO received a $450,000 fine, for distributing its orthopedic devices without approval as part of a $1 million settlement against the orthopedic device firm.
The company was fined $550,000 for marketing its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance, according to a statement from the U.S. Food and Drug Administration.
The settlement was reached following a civil complaint filed by the FDA in November 2011.
Globus Medical Inc., an Audubon, Pennsylvania-based company near Philadelphia,had sought approval for its NuBone device in January 2009, but the FDA did not grant it after finding the device was not substantially equivalent to other products on the market. Globus Medical distributed the device anyway, despite receiving a letter turning down the product in December 2009, the statement said.
The move to fine the medical device company’s CEO reflects a toughened stance against companies that violate its policies. The FDA has a number of enforcement tools to hold corporate officials accountable, particularly at pharmaceutical companies, for off-label use.
Dara A. Corrigan, associate commissioner for regulatory affairs, said in the statement: “This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices. By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices.”