Food and Drug Administration: Improvements Needed in the Foreign Drug Inspection Program

by Bernice Steinhardt (Editor)

It examines FDAs efforts prepare inspection reports & take enforcement actions against foreign pharmaceutical manufacturers in a timely manner; improve the consistency with which FDA evaluates the results of foreign inspections & conducts reinspections to verify that foreign pharmaceutical manufacturers have corrected serious deficiencies; conduct routine inspections of foreign pharmaceutical manufacturers to monitor their compliance with U.S. quality standards; & improve the management of data needed for planning inspection, monitoring inspection results, & taking enforcement actions. Charts & tables.

47 pages, Paperback

First published June 1, 1998