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Update on Augment Pre-Approval Inspection

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JJC3   Tuesday, 02/03/15 01:09:13 PM
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Update on Augment Pre-Approval Inspection

Wright also announced that one of its vendors received a Form 483 at completion of a recent FDA pre-approval inspection for Augment® Bone Graft. The 483 cited several observations. The vendor has submitted a full response to FDA that the vendor and the Company believe will satisfactorily address the FDA's observations. Based on this, Wright continues to anticipate final approval of Augment® Bone Graft in the first half of 2015 but believes a first quarter approval is unlikely.

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