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.