LIMERICK, Pa.--(BUSINESS WIRE)--Oct. 15, 2007--Teleflex
Incorporated (NYSE:TFX) today 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.
CONTACT: Teleflex Incorporated
Julie McDowell, 610-948-2836
Vice President, Corporate Communications
SOURCE: Teleflex Incorporated