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CDRH Director Shuren: Preventive Actions Could Curb FDA Warning Letters

This article was originally published in The Silver Sheet

Executive Summary

PREVENTIVE ACTIONS COULD HELP WARD OFF WARNING LETTERS, CDRH Director Jeffrey Shuren says, noting that "by the time a warning letter goes out the door, [a firm] likely already has a problem." At the same time, the agency has taken steps to ensure that warning letters are issued faster by giving companies only 15 business days to respond to an FDA-483 inspection form. The initiative comes at a time when 46 percent of quality-related warning letters released in 2009 were issued more than four months after a facility inspection, according to a "Silver Sheet" analysis. FDA also expects the warning letter process to speed up now that the Office of Chief Counsel will review only those letters that raise "significant legal issues." Meanwhile, the number of warning letters remained steady in 2009, although MDR violations spiked because of warnings issued to LASIK centers
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