Inspections and Audits

U.S.-EU Partnership on GMP Inspections Adds Five Countries

The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Read More

Florida Drugmaker Called Out for Quality Issues

“The absence of a hole in the tablet will significantly change the dissolution profile and cause out of specification dissolution rates that could adversely impact the therapeutic effect of the drug product,” the agency warned. Read More