The QMN Weekly Bulletin

CDRH Warning Letters, Recalls on Rise in Recent Years: Report

March 8, 2013
The Center for Devices and Radiological Health issued a third more warning letters in 2011 than in 2008 and doubled the number of recalls over the same period, an independent report on FDA enforcement actions shows. Overall, CDRH issued 200 warning letters in 2010, up from 152 in 2008. Adulteration, which includes GMP and quality system violations, accounted for 83 percent of the warnings, according to the report.
The GMP Letter