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IART > SEC Filings for IART > Form 8-K on 14-Aug-2013All Recent SEC Filings

Show all filings for INTEGRA LIFESCIENCES HOLDINGS CORP | Request a Trial to NEW EDGAR Online Pro



Other Events

Item 8.01 Other Events.

On August 14, 2013, the United States Food and Drug Administration (the "FDA") completed an inspection of the regenerative medicine facility in Plainsboro, New Jersey (the "Plainsboro Facility") of Integra LifeSciences Corporation, a wholly-owned subsidiary of Integra LifeSciences Holdings Corporation (the "Company"). The Plainsboro Facility is operating subject to an FDA warning letter dated December 21, 2011 (the "Warning Letter") that relates to quality systems and compliance issues. The inspection began on July 16, 2013 and focused primarily on the issues raised in the Warning Letter and in previous inspections of the Plainsboro Facility. At the conclusion of the inspection, the FDA found that the Company had addressed the issues raised in the Warning Letter and previous inspectional observations, and it issued no other inspectional observations. In reaching this conclusion, the FDA determined that the Company's remediation activities were effective and its quality management system was adequate.

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