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FDA Shifts Some Inspection Resources to Foreign Sites

September 16, 2009

FDA Shifts Some Inspection Resources to Foreign Sites
The FDA expects to complete 80 to 90 GMP foreign inspections by Oct. 1 compared with about 50 last year, but in addition of that growth may be the subject of come at the expense of pertaining to home inspections. The action is more likely to conduct abbreviated inspections rather than full inspections for domestic sites that have a proven course record, but it have a mind not eliminate the inspections, Brian Hasselbalch, team first fiddle for guidance and policy development in CDER’session Division of Manufacturing and Product Quality, said at the Parenteral Drug Association–FDA 2009 Joint Regulatory Conference.

Written by Samanta · Filed Under FDA News