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IART > SEC Filings for IART > Form 8-K on 13-Nov-2012All Recent SEC Filings

Show all filings for INTEGRA LIFESCIENCES HOLDINGS CORP

Form 8-K for INTEGRA LIFESCIENCES HOLDINGS CORP


13-Nov-2012

Regulation FD Disclosure


ITEM 7.01 REGULATION FD DISCLOSURE

Attached as Exhibit 99.1 and incorporated into this Item 7.01 by reference is the warning letter, dated November 1, 2012, from the United States Food and Drug Administration (the "FDA") to Integra NeuroSciences Ltd., a wholly-owned indirect subsidiary of Integra LifeSciences Holdings Corporation (the "Company"). The warning letter related to quality systems issues at its manufacturing facility located in Andover, England. The letter, which was received on November 5, 2012, resulted from an inspection held at that facility in June 2012.

The warning letter does not restrict the Company's ability to manufacture or ship products or import them in to the United States. It also does it require the recall of products. The Company has provided detailed responses to the FDA as to its corrective actions on a monthly basis and, since the conclusion of the inspection, has undertaken significant efforts to remediate the observations.

The Andover facility manufactures components of the CUSA ultrasonic aspirator system, and intracranial pressure monitors. Sales of products manufactured in the Andover facility constituted less than 3% of the Company's consolidated revenues in the twelve months ended September 30, 2012. The Company does not expect to incur material incremental expense in the fourth quarter of 2012 on remediation activities.

The Company disclosed the warning letter in a press release issued concurrently with the filing of this Current Report on Form 8-K.

The information contained in Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section. The information contained in Item 7.01 of this Current Report on Form 8-K shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits.

Exhibit Number         Description of Exhibit

99.1                   Letter dated November 1, 2012 from the United States Food and
                       Drug Administration to Integra NeuroSciences Ltd.


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