Teleflex Medical Resolves FDA Corporate Warning Letter
6/20/2011 10:14:32 AM
LIMERICK, Pa.--(BUSINESS WIRE)--Teleflex Incorporated (NYSE:TFX), a global provider of medical technology products, announced today that it has received formal notification that it has successfully resolved all outstanding issues raised by the U.S. Food and Drug Administration (FDA) in a corporate Warning Letter received by its subsidiary, Arrow International (Arrow). The Warning Letter was received in October of 2007, and identified FDA’s observations on a variety of Arrow’s quality systems control measures that occurred prior to Teleflex’s acquisition of Arrow. The FDA notified the Company that its response and the actions that have been adopted and implemented have sufficiently addressed the FDA’s observations.