PLAINSBORO, N.J., Feb. 19, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that on February 14, 2013, 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 Añasco, Puerto Rico. The letter resulted from an inspection conducted at that facility during October and November 2012. The Company has provided certain additional information relating to the matters set forth in this press release, as well as 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 cites concerns relating to process validations, corrective and preventative actions, and document controls. Integra believes that it has already substantially remediated the issues addressed in the warning letter, and is in the process of having third-party consultants assess its procedures and processes to ensure that products are manufactured in accordance with applicable regulations, as recommended by FDA.
The Añasco facility manufactures several of Integra's collagen products, including Duragen® Dural Graft Matrix and several OEM products sold to strategic partners through our Private Label business. Sales of products manufactured or packaged in the Añasco, Puerto Rico facility constituted approximately 18% of Integra's consolidated revenues during 2012. The Company also has the capability to produce most of the relevant products in its Plainsboro, New Jersey facility.
Please refer to the Form 8-K filed concurrently with this press release for more information.
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.
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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.