Teleflex Announces That Arrow International Has Received FDA Corporate Warning Letter

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 16 Oct 2007 - 8:00 PDT

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Teleflex Incorporated (NYSE:TFX) has announced that its subsidiary, Arrow International (Arrow) has received a corporate warning letter from the Philadelphia District Office of the U.S. Food and Drug Administration (FDA). The FDA warning cites three site-specific warning letters issued in 2005 and subsequent inspections performed from June 2005 to February 2007 at Arrow's facilities in the United States.

The letter expresses concerns with Arrow's quality systems, including complaint handling, corrective and preventive action, process and design validation, inspection and training procedures. It also advises Arrow that its corporate-wide program to evaluate, correct and prevent quality system issues has been deficient. Limitations on pre-market approvals and certificates of foreign goods had previously been imposed on Arrow based on prior inspections and the corporate warning letter does not impose additional sanctions that are expected to have a material financial impact on the company.

Arrow has been actively working to address the FDA's findings and has been conducting a thorough review of its quality systems. Ongoing updates have been provided to the FDA outlining corrective and preventive actions.

Teleflex acquired Arrow International on October 1, 2007 and its integration plan includes the commitment of significant resources to correct these previously-identified regulatory issues and further improve overall quality systems. The company will promptly respond to the warning letter. "We recognize the seriousness of this warning letter and will work closely with the FDA to resolve outstanding issues," said Ernest Waaser, President of Teleflex Medical. "Addressing the FDA's concerns is and will be of the highest priority."

About Teleflex:

Teleflex Incorporated is a diversified company with pro forma annual revenues over $3 billion. The company designs, manufactures and distributes quality-engineered products and services for the medical, commercial, and aerospace markets worldwide. Teleflex employs more than 23,000 people worldwide who focus on providing innovative solutions for customers.

Caution Concerning Forward-looking Information:

This press release may contain forward-looking statements. Actual results could differ materially from those in these forward-looking statements due to, among other things, the company's ability to fully address the concerns of the FDA as planned at the time of acquisition, unanticipated expenditures in connection with integration programs; unanticipated difficulties in connection with integration programs; and other factors described in Teleflex's and Arrow's filings with the Securities and Exchange Commission.

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