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Warning Letters To Foreign Firms Rise; FDA Inspection Cadre Yields Big Impact

This article was originally published in The Silver Sheet

Executive Summary

FDA’s device center is sending a record number of warning letters to foreign facilities as the agency continues its efforts to more effectively oversee product manufacturing located outside the U.S.

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Analysis: Foreign Firms Hit With Majority Of FDA Quality-Linked Warning Letters Last Year

Most of the 150 warning letters issued by FDA last year were sent to foreign manufacturers, a “Silver Sheet” analysis shows. That letters to overseas companies have outpaced those to domestic ones is a surprise given that the agency performs nearly four times as many inspections of U.S.-based facilities each year. But the foreign warning letter increase in 2013 might actually be a sign that FDA’s enhanced focus on overseas compliance in recent years has begun paying dividends. In related warning letter trends, CAPA has supplanted complaint handling as the No. 1 deficiency area cited in letters. Further, 56 close-out letters were sent to firms in 2013, down slightly from 2013.

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.

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

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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