Inspections and Audits

EEA Third-Country GMP Inspections Drops in 2016

Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More

FDA to Recognize GMP Inspections From Eight EU Countries

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More

FDA Highlights ConOps Progress at FDLI Conference

ORA and CDER officials provided an update on the agency’s Concept of Operations initiative in a Thursday panel discussion at the FDLI’s Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More