Integra LifeSciences Receives Warning Letter in Andover, England Manufacturing Facility
PLAINSBORO, N.J., Nov 13, 2012 (Menafn - GlobeNewswire via COMTEX) --Integra LifeSciences Holdings Corporation IART announced today that on November 5, 2012 it received a warning letter from the United States Food and Drug Administration (FDA) related to quality systems issues at its manufacturing facility located in Andover, England. The letter resulted from an inspection held at that facility in June 2012. The Company has provided a copy of the warning letter as an exhibit in a Current Report on Form 8-K filed concurrently with the issuance of this press release.
The warning letter does not restrict the company's ability to manufacture or ship products or import them into the United States. It also does not require the recall of products. The company has provided detailed responses to 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 Integra's consolidated revenues in the twelve months ended September 30, 2012. The Company does not expect to incur material incremental expense during the fourth quarter on remediation activities.
Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery. For more information, please visit www.integralife.com
Statements made in this release may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors include, but are not limited to, future plans, expectations and financial performance, governmental approvals and other actions of governmental bodies, including the U.S. Food and Drug Administration. These risks and uncertainties include market conditions and other factors beyond the Company's control, the ability to remediate quality systems violations and the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2011 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results. These forward-looking statements are made only as the date thereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE: Integra LifeSciences Holdings Corp.
CONTACT: Integra LifeSciences Holdings Corporation
John B. Henneman, III
Executive Vice President
Finance and Administration
and Chief Financial Officer
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