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

This article was originally published in The Silver Sheet

Executive Summary

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.

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