The FDA has reached a $1 million civil money penalty settlement with Globus Medical Inc. for the distribution of unapproved medical devices, according to an FDA news release.
A 2010 inspection revealed that the company had marketed its NuBone Osteoinductive Bone Graft product without prior approval or clearance. The settlement requires the Pennsylvania-based medical device firm to pay a $550,000 penalty and the firm's CEO, David Paul, to pay a $450,000 penalty, for a total of $1 million.
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A 2010 inspection revealed that the company had marketed its NuBone Osteoinductive Bone Graft product without prior approval or clearance. The settlement requires the Pennsylvania-based medical device firm to pay a $550,000 penalty and the firm's CEO, David Paul, to pay a $450,000 penalty, for a total of $1 million.
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