Section 20: GCP Compliance Statistics and Trends (Data on U.S. FDA Inspections) Number of Inspections 800 CDER BIMO Inspections, FY2006-FY2013* 843 793 754 725 681 702 683 671 600 Spon CI IRB/RDRC BIOEQ GLP 400 200 0 06 07 08 09 10 11 12 13 Number of CDER BIMO Inspections in FY2013 and FY2012 by Type FY2013 FY2012 Clinical Investigator 361 381 Bioequivalence 207 161 IRB 89 88 GLP 29 36 Sponsor/Monitor/CRO 68 59 Number of FDA Clinical Investigator Inspections by Center, FY2013 and FY2012 FY2013 361 Center for Drug Evaluation and Research FY2012 381 Center for Biologics Evaluation and Research 91 93 Center for Devices and Radiological Health 193 194 Total 645 668 687