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Corporate warning letter sent to Arrow International

This article was originally published in The Silver Sheet

Executive Summary

An FDA corporate warning letter has been issued to Teleflex subsidiary Arrow International in an effort to compel the company to clean up various quality systems problems at its manufacturing facilities. The corporate letter - only the fourth issued in CDRH's history - cites three warning letters sent by the agency in 2005, as well as FDA facility inspections conducted from June 2005 through February 2007. According to the company, the FDA corporate letter expresses concerns about Arrow's procedures for complaint handling, corrective and preventive action, process and design validation, quality audits, and training. The letter also notes that the firm's program to evaluate, correct and prevent quality systems issues was deficient. "We recognize the seriousness of this warning letter and will work closely with the FDA to resolve outstanding issues," Teleflex Medical President Ernest Waaser says. Boston Scientific was the recipient of the most recent previous corporate letter issued by FDA, in January 2006 ("The Silver Sheet" March 2007)

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