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Teleflex/Arrow corporate warning letter

This article was originally published in The Gray Sheet

Executive Summary

Teleflex subsidiary Arrow International receives corporate warning letter from FDA dated Oct. 10 expressing concerns with Arrow's company-wide quality systems, including procedures for complaint handling, corrective and preventative action, process and design validation, inspection and training. The letter cites three site-specific warning letters issued in 2005 and subsequent inspections performed from June 2005 to February 2007 at Arrow's U.S. facilities, which make catheters and other critical- and cardiac-care devices (1"The Gray Sheet" June 27, 2005, p. 19). FDA had already imposed limitations on Arrow's premarket approvals and certificates to foreign governments based on the prior inspections, and has not imposed any additional sanctions that will have a material financial impact on the company, according to Teleflex. Teleflex, which acquired Arrow on Oct. 1, says it will respond to the letter promptly
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