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March 28, 2007

Warning Letters Drop 24% In 2006; FDA Weighs Additional 'Corporate' Letters

From the March 2007 issue of "The Silver Sheet"

The volume of FDA quality system warning letters fell 24 percent in 2006, but not necessarily because the device industry has become more cognizant of Quality System Regulation requirements, FDA acknowledges. Rather, limited agency resources and a high investigator turnover rate could be to blame, officials say.

FDAers caution manufacturers against interpreting the dip in warning letters as a sign that the agency is less keen on enforcement, noting that it is considering issuing more “corporate” warning letters this year.

“I think it’s surprising to the American public in many cases that some large, well-known companies do have ... problems,” says Tim Ulatowski, director of CDRH’s Office of Compliance.

Meanwhile, separate agency-wide and CDRH-specific reviews of the warning letter system are ongoing.

This article continues in the March 2007 issue of "The Silver Sheet"

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Also covered in this issue:

COMPLETE LISTING of QS warning letters released in 2006 includes several leading firms.

WARNING LETTERS: Edwards Lifesciences cited for QS and MDR reg violations; complaint handling and CAPA violations cited at GE Healthcare Technologies.

IN BRIEF: Industry collaboration aims to diffuse problems with infusion pumps; CDRH and vendor test electronic adverse event submission software.

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