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Debate Grows Around Timeliness Of FDA Close-Out Letters; Warning Letters Going Out Faster

This article was originally published in The Silver Sheet

Executive Summary

Writing a thorough warning letter response just might help a manufacturer receive an FDA close-out letter more quickly. A well-crafted response can help the agency decide whether to close out some warning letters without performing a reinspection. “If we can conduct a paper review of a firm that has revamped its MDR [Medical Device Reporting] processes, and we find those MDR processes acceptable based on the paper review, then we may be able to close out the warning letter,” CDRH Office of Compliance Director Steven Silverman said. Because it can take a long time for FDA to revisit a firm, the close-out process has slowed to a crawl, some experts say. In warning letter news, FDA is pushing letters out the door faster. There were 121 quality-related letters posted on the agency’s website in 2011, an increase of 30 percent over the prior year.

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Record Number Of Warning Letters Issued In 2012; Complaint Handling Troubles Significant

Device manufacturers were sent an historic number of warning letters by FDA last year, eclipsing the previous high from 1997. FDA has not yet completed its own analysis of 2012 warning letter trends, but an ex-agency official says there are several likely reasons for the increase. FDA’s Office of Chief Counsel “is no longer throwing cold water on letters. Investigators are being trained a lot better and are becoming more experienced. And certainly the Office of Compliance and CDRH are under new management. You put all of those things together and I think that’s the answer,” says Michael Chappell, a former FDA associate commissioner for regulatory affairs. The number of foreign warning letters also increased in 2012, comprising 39 percent of overall letters. In another first for warning letters last year, complaint handling supplanted CAPA as the violation found most in letters. Further, four former FDA officials share tips for writing warning letter responses to FDA.

Root Cause Analysis A Key Element Of FDA’s ‘Case For Quality’

CDRH is highlighting poor root cause analysis as part of its “Case for Quality,” an initiative that encourages companies to make quality assurance an organization-wide concern. Since FDA directed firms in 2009 to write FDA-483 response letters within 15 workdays after an inspection, the agency has been concerned that companies might feel compelled to fix every citation listed on the inspection form quickly without considering root causes. “What we are worried about is that this perceived need to respond in such a manner may prevent firms from taking time for a greater root cause assessment of the systemic problems that gave rise to the FDA-483 citations,” CDRH Office of Compliance Director Steven Silverman said. The Case for Quality will also examine how companies are inspected and how to make device quality data more accessible to firms.

Teleflex Turned Around Arrow’s Quality System Following FDA Corporate Warning Letter

When an FDA corporate warning letter was sent to Arrow International in 2007 outlining numerous quality system deficiencies, the new owner of the troubled device company knew that drastic steps had to be taken. “This is a story about what can happen to a company, the compliance issues it can become involved in, and more importantly, the steps we took to remediate all of those issues and bring the company back into a healthy compliance mode,” said Michael Crader, VP of global RA/QA at Teleflex. Work to fix Arrow’s quality system began with an analysis of the firm’s data and a shutdown of Arrow plants across the globe. Quality system teams were formed to tackle five key areas: management control, CAPA, production and process control, materials and change management, and design control.

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