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 some of that growth may have come at the expense of domestic inspections. The agency is more likely to conduct abbreviated inspections rather than full inspections for domestic sites that have a proven track record, but it will not eliminate the inspections, Brian Hasselbalch, team leader for guidance and policy development in CDER’s Division of Manufacturing and Product Quality, said at the Parenteral Drug Association–FDA 2009 Joint Regulatory Conference.
Drug Industry Daily