FDA PRE-APPROVAL INSPECTION TURNDOWNS DECLINE TO 29%
Executive Summary
FDA PRE-APPROVAL INSPECTION TURNDOWNS DECLINE TO 29% for the year ended March 1 from 38% a year earlier. According to FDA field management records, the agency conducted 325 pre-approval inspections during the year, 94 of which resulted in field office recommendations that approval of the NDA or ANDA under review be withheld pending resolution of the problems uncovered.