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IART > SEC Filings for IART > Form 8-K on 3-Dec-2013All Recent SEC Filings




Other Events, Financial Statements and Exhibits

Item 8.01 Other Events.

On November 26, 2013, the United States Food and Drug Administration (the "FDA") completed an inspection of the regenerative medicine facility in Aņasco, Puerto Rico (the "Aņasco Facility") of Integra LifeSciences Corporation, a wholly-owned subsidiary of Integra LifeSciences Holdings Corporation (the "Company"). The Aņasco Facility is operating subject to an FDA warning letter dated February 13, 2013 (the "Warning Letter") that relates to quality systems and compliance issues. The inspection began on October 25, 2013 and focused primarily on the issues raised in the Warning Letter. At the end of the inspection, the FDA issued a new Form 483 with six observations, relating to Corrective and Preventative Action ("CAPA"), quality system procedures and instructions, procedures pertaining to complaints, procedures pertaining to checking and maintaining equipment, procedures for finished device acceptance and procedures to prevent contamination of equipment or products. Of these, the FDA designated the first observation, related to CAPA, and the third observation, related to complaint procedures, as repeat observations. The FDA did not issue repeat observations about validated processes, document control procedures, process control procedures or schedules for the adjustment, cleaning and maintenance of equipment The Company had committed to several corporate-wide corrections and additional site corrections and will continue to complete these within the timeframes provided to the FDA in order remediate the observations that the FDA has made. A copy of the FDA Form 483 is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1* Food and Drug Administration Form FDA-483, dated November 26, 2013, relating to the inspection of the Aņasco Facility

* Application has been made to the Commission for confidential treatment of certain provisions of this exhibit. Omitted information for which confidential treatment has been requested has been filed separately with the Commission.

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