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.