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QS Warning Letter Numbers Remain Low Under HHS Review Policy

This article was originally published in The Silver Sheet

Executive Summary

QUALITY SYSTEM WARNING LETTERS released in 2003 are legally stronger as a result of higher thresholds imposed by FDA’s Office of Chief Counsel, although fewer letters are being issued than in the past. Over two-thirds of last year’s 67 device QS warning letters cite CAPA violations, a perennial trouble spot. CDRH Office of Compliance Director Tim Ulatowski discusses his top areas of concern, including manufacturer root cause analysis and complaint handling, while Smiths Medical exec Russ Davies and Washington, D.C. attorney Donald Segal offer advice to industry on handling FDA inspections





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