LONDON (Thomson Financial) - Teleflex Incorporated said its subsidiary,
Arrow International has received a corporate warning letter from the
Philadelphia District Office of the US 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.
Teleflex said Arrow has already had limitations on pre-market approvals and
certificates of foreign goods imposed upon it 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.
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 said it 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.
Teleflex designs, manufactures and distributes products and services for the
medical, commercial, and aerospace markets worldwide.
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