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

This article was originally published in The Silver Sheet

Executive Summary

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.

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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.

Year In Review: Complaint Handling, UDI, FDA Inspections, And More

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