Number of FDA BIMO Inspections Decreased in FY 2019

J.W. Schomisch
June 28, 2020 at 10:58 AM EST
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The number of bioresearch monitoring (BIMO) inspections decreased in fiscal year (FY) 2019, falling 12 percent to 1,107 inspections after jumping 31 percent in FY 2018 to 1,261 inspections from 965 in FY 2017, according to the agency’s annual metrics report. There were 1,055 BIMO inspections in FY 2016, 1,113 inspections conducted in FY 2015 and 1,136 inspections in FY 2014.

The number of BIMO inspections had been increasing each year since FY 2011 when there were 949 inspections. The number increased by 8 percent in FY 2012 to 1,024. That number held nearly steady in FY 2013 with 1,019 inspections and then increased 11.5 percent in FY 2014 to 1,136. FY 2011 had been the first time in years the number of BIMO inspections had dropped below 1,000. There were 1,169 BIMO inspections conducted in FY 2010, 1,135 in FY 2009, 1,010 in FY 2008, 1,024 in FY 2007 and about 1,100 inspections each in FY 2005 and 2006.

In FY 2019, the FDA conducted 779 clinical investigator inspections, which was a 10 percent decrease from the 861 clinical investigator inspections conducted in FY 2018. The FDA conducted 701 clinical investigator inspections in FY 2017. As with total inspections, the number of clinical investigator inspections had been dropping for the three previous years. The 701 inspections in FY 2017 was a 9.5 percent drop from the 775 clinical investigator inspections conducted in FY 2016, which was itself a 9.4 percent drop from the 822 clinical investigator inspections in FY 2015. There were 803 investigator inspections in FY 2014.

The number of institutional review board (IRB) inspections also fell 14 percent to 140 inspections from the 163 inspections in FY 2018, which had been a 31 percent increase from 124 conducted in FY 2017. FY 2017 had held steady from FY 2016, after the number of IRB inspections had decreased steadily in the previous four years. There were 138 IRB inspections in FY 2015, 152 IRB inspections in FY 2014 and 171 IRB inspections in FY 2013.

The number of sponsor/monitor/clinical research organization inspections also decreased by nearly 30 percent to 113 from 170 in FY 2018. There were 106 such inspections in FY 2017, while there were 112 in FY 2016, 117 in FY 2015, and 138 in FY 2014. The number of sponsor/monitor/CRO inspections in FY 2013 was 98. The agency also conducted 13 separate sponsor/investigator inspections in FY 2019 after conducting 11 in FY 2017, which was the first year the FDA had broken out sponsor/investigator inspections.

The agency also conducted 62 laboratory inspections in FY 2019, which was a slight increase over the 56 laboratory inspections in FY 2018, which itself had been a 65 percent increase from the 34 conducted in FY 2017. There were 44 laboratory inspections in FY 2016, 36 in FY 2015, 43 in FY 2014 and 46 in FY 2013.

BIMO Inspections by FDA Center

Overall, the Center for Drug Evaluation and Research (CDER) continued to conduct the majority of inspections, accounting for nearly 70 percent of the FY 2019 FDA BIMO inspections, which was up from the 63 percent of the FY 2018 inspections and 60 percent of the FY 2017 inspections. The FY 2017 percentage was down slightly from the 61.5 percent of the FY 2016 inspections but up slightly from the 59 percent of the FY 2015 and FY 2014 inspections. The 758 CDER FY 2019 BIMO inspections was down slightly from the 790 CDER inspections in FY 2018 but still up considerably from the 581 CDER BIMO inspections in FY 2017. There were 649 CDER BIMO inspections in FY 2016, 656 in FY 2015, 675 in FY 2014, 524 in FY 2013, 564 inspections in FY 2012, 490 inspections in FY 2011, 586 in FY 2010 and 669 in FY 2009.

The Center for Devices and Radiological Health (CDRH) accounted for nearly 20 percent of the FY 2019 BIMO inspections with 215, which was more than 100 fewer than the 349 CDRH BIMO inspections in FY 2018. This was the most CDRH BIMO inspections since FY 2010 when the center conducted 386 inspections. There were 287 CDRH BIMO inspections in FY 2017, 270 in FY 2016, 301 in FY 2015, 313 in FY 2014 and 332 in FY 2013. The 2013 number was a nearly 9 percent increase from the 305 BIMO inspections CDRH conducted in FY 2012. CDRH conducted 321 inspections in FY 2011, 386 in FY 2010, 305 in FY 2009, 301 in FY 2008 and 323 in FY 2007.

The Center for Biologics Evaluation and Research (CBER) conducted 88 BIMO inspections (about 8 percent of the total) in FY 2018, which was 10 fewer than the 98 conducted in FY 2018. CBER conducted 97 BIMO inspections FY 2017, 106 BIMO inspections in FY 2016, 115 in FY 2015, 121 in FY 2014, which was the most the center has conducted since FY 2010, when it conducted 125 BIMO inspections. CBER conducted 104 BIMO inspections in FY 2013, 115 in FY 2012 and 99 in FY 2011. CBER conducted 115 BIMO inspections in FY 2009, 106 in FY 2008 and 130 in FY 2007.

The Center for Veterinary Medicine (CVM) conducted 34 BIMO inspections in FY 2019, which was 10 more than the 24 FY 2018 inspections. CVY did not conduct any BIMO inspections in FY 2017. CVM conducted 27 BIMO inspections in FY 2016, 34 in FY 2015, 25 in FY 2014, 59 in FY 2013, 40 in FY 2012, 39 in FY 2011, 72 in FY 2010, 45 in FY 2009, and 55 in FY 2008.

Investigators Top Inspection List

Once again, the vast majority of FY 2019 BIMO inspections (779 or 70 percent) were of clinical investigators. There were 790 clinical investigator inspections in FY 2018, 701 in FY 2017 and 775 in FY 2016. The FDA BIMO program conducted 822 clinical investigator inspections in FY 2015, which was the highest annual number of investigator inspections in the past eight years. The FDA conducted 803 clinical investigator inspections in FY 2014, 664 in FY 2013, 697 in FY 2012, 576 in FY 2011, 725 in FY 2010 and 730 in FY 2009.

CDER conducted nearly three-quarters (74 percent) of the FY 2018 investigator inspections with 574. CDER conducted two-thirds (64 percent) of the FY 2018 investigator inspections with 547, which was a 31 percent increase over the 419 (60 percent) CDER conducted in FY 2017. In FY 2016 CDER conducted 478 investigator inspections (61 percent). CDER conducted 58 percent of the FY 2015 investigator inspections (483); 59 percent of the FY 2014 investigator inspections (472); 48 percent of the FY 2013 investigator inspections (344); 55 percent of the FY 2012 investigator inspections (383); 54.7 percent (315) in FY 2011; 54 percent (393) in FY 2010; and 62 percent in FY 2009 (458). CDER conducted 405 clinical investigator inspections in FY 2008, 367 in FY 2007 and 403 in FY 2006.

Traditionally, CDRH conducts about a quarter of the investigator inspections. However, in FY 2019, CDRH conducted only 126 investigator inspections (11 percent). CDRH conducted 226 (26 percent) investigator inspections in FY 2018, 198 (28 percent) in FY 2017 and 184 (24 percent) in FY 2016. In FY 2015 (211) and FY 2014 (203), CDRH also conducted about 25 percent of the inspections. CDRH conducted 29 percent (193) of the investigator inspections in FY 2013 and 28 percent (194) in FY 2012, which was a 12 percent increase from the 173 inspections CDRH conducted in FY 2011. CDRH conducted 218 investigator inspections in FY 2010, and 163 in FY 2009. Of CDRH’s FY 2011 inspections, 63 percent were of clinical investigators.

Nearly 70 percent (60) of CBER’s FY 2019 BIMO inspections were of clinical investigators, which continues a percentage drop that has been going on for several years. In FY 2018, more than three-quarters (77 percent) of CBER’s inspections were of clinical investigators (75 inspections), while 87 percent of CBER’s FY 2017 BIMO inspections were of clinical investigators (84 inspections). In both FY 2016 (106 inspections) and FY 2015 (101 inspections) clinical investigator inspections accounted for 88 percent of CBER’s total BIMO inspections. In FY 2014, 90 percent (109) of CBER’s BIMO inspections were of clinical investigators, which was the most the Center ever conducted. The Center conducted 91 investigator inspections in FY 2013, 93 in FY 2012, 62 in FY 2011, 75 in FY 2010, 83 in FY 2009, and 77 in FY 2007 and again in 2008.

CVM conducted 12 investigator inspections in FY 2019, one more than the center did in FY 2018, after CVM conducted no investigator inspections in FY 2017. CVM conducted 19 investigator inspections in FY 2016, which was four less than the 23 in FY 2015. CVM conducted 18 investigator inspections in FY 2014, 36 in FY 2013, 27 in FY 2012, 26 in FY 2011, 45 in FY 2010, 26 in FY 2009 and 38 in FY 2008.

The Center for Food Safety and Nutrition (CFSAN) conducted two clinical investigator BIMO inspections in FY 2019 after reporting none in FY 2017 and 2018 and one each in both FY 2015 and 2016. The Center for Tobacco Products (CTP) conducted five clinical investigator BIMO inspections in FY 2019 after conducting none in FY 2016, 2017 or 2018. CTP conducted three clinical investigator inspections in FY 2015.

IRB Inspections Decrease

The number of IRB inspections dropped 14 percent to 140 in FY 2019 after the number had jumped 31 percent to 163 inspections in FY 2018. The number of IRB inspections had remained steady at 124 in FY 2016 and 2017. The FDA Centers conducted 138 IRB inspections in FY 2015, 152 in FY 2014, 174 in FY 2013, 158 in FY 2012, 187 in FY 2011, 203 in FY 2010, 196 in FY 2009, 179 in FY 2008, and 221 in FY 2007.

CDER again conducted the most IRB inspections with 90 in FY 2019, which was a 14 percent drop from the 105 CDER conducted in FY 2018. The 105 IRB inspections had been a 33 percent increase over the 79 conducted in FY 2017. The FY 2018 totals included four radioactive drug research committee (RDRC) inspections, while the FY 2017 total includes two RDRC inspections. There were no RDRC inspections in FY 2019. There were 81 CDER IRB inspections in FY 2016, including one RDRC inspection. CDER conducted 83 IRB inspections in FY 2015, which included four RDRC inspections. CDER had conducted 90 IRB inspections in FY 2013 and again in 2014. CDER conducted 88 IRB inspections in FY 2012, 103 in FY 2011, 97 in FY 2010, 102 in FY 2009, 72 in FY 2008, 101 in FY 2007 and 55 in FY 2006. The number of CDER IRB inspections is still down considerably from the 250 IRB inspections the Center conducted each year between 2000 and 2002.

CDRH conducted 37 IRB inspections in FY 2019, which was 18 fewer than the 55 IRB inspections in FY 2018. CDRH conducted 48 IRB inspections in FY 2017, 35 in FY 2016, 42 in FY 2015, 52 in FY 2014, 76 in FY 2013, 56 in FY 2012, 62 in FY 2011, 81 in FY 2010, 79 in FY 2009, 88 in FY 2008, 92 in FY 2007 and 50 in FY 2006.

CBER conducted a dozen IRB inspections in FY 2019, which was a four-fold increase over the three IRB inspections the Center conducted in FY 2018. CBER conducted 10 IRB inspections in FY 2017, seven in FY 2016, 11 in FY 2015, eight in both FY 2013 and FY 2014, 14 in FY 2012, 22 in FY 2011, 25 in FY 2010, 15 in FY 2009, 19 in FY 2008 and 28 in FY 2007.

CFSAN conducted one BIMO IRB inspection in FY 2019 after conducting none in FY 2017 or 2018. The Center conducted one BIMO IRB inspection in FY 2016 and two in FY 2015.

Sponsor/Monitor/CRO Inspections Up

After several years of the number of sponsor/monitor/CRO inspections decreasing, the number increased 12 percent to 113 in FY 2019 from 101 inspections in FY 2018. There were 106 such inspections in FY 2017, 112 in FY 2016, 117 in FY 2015 and 138 in FY 2014. There were 120 sponsor/monitor/CRO inspections in FY 2013 and 109 in FY 2012. There were 141 sponsor inspections in FY 2011, 155 inspections in FY 2010, 147 in FY 2009 and 109 in FY 2008. The numbers for FY 2008-2017 include inspections of sponsor/investigators, which the agency did not break out.

The FDA listed 13 sponsor/investigator BIMO inspections in FY 2019 and 11 in FY 2018. CDER conducted the majority of sponsor/investigator BIMO inspections in FY 2019 with seven. CDRH and CBER conducted three each. In FY 2018, CBER conducted the majority with seven and both CDER and CDRH conducted two each.

For the eighth year, CDER conducted more sponsor inspections than CDRH. In FY 2019 CDER conducted 62 sponsor/monitor/CRO inspections. CDRH conducted 39, CBER conducted nine and CVM conducted three. In FY 2018, CDER nearly doubled CDRH’s number of sponsor inspections with 101 compared with 54 for CDRH. In FY 2017, CDER conducted 55 sponsor inspections while CDRH conducted 48. In FY 2016, CDER conducted 58 sponsor inspections while CDRH conducted 46. In FY 2015, CDER conducted 66 sponsor inspections, while CDRH conducted 47. In FY 2014, CDER conducted 83 sponsor inspections compared to 51 for CDRH. In FY 2013, CDER conducted 62 sponsor inspections compared with 53 by CDRH. In FY 2012, CDER conducted 57 sponsor inspections, while CDRH conducted 44.

CDER conducted 45 sponsor inspections in FY 2011, 61 in FY 2010, 73 in FY 2009, 43 in FY 2008 and 23 in FY 2007. CDRH conducted 78 sponsor inspections in FY 2011, 80 in FY 2010, 59 in FY 2009, 57 in FY 2008 and 53 in FY 2007.

CBER conducted 13 sponsor/monitor/CRO inspections in FY 2018, three in FY 2017, two in FY 2016 and one in FY 2015. CBER conducted three sponsor inspections in FY 2014, and four in both FY 2012 and 2013. CBER conducted 12 sponsor inspections in FY 2011, 14 in FY 2010, 11 in FY 2009, six in FY 2008 and 12 in FY 2007.

CVM conducted two sponsor inspections in FY 2018 after conducting none in FY 2017. CVM conducted two sponsor inspections in FY 2016, three in FY 2015, one in FY 2013 and 2014, four in FY 2012, six in FY 2011, one in FY 2010, four in FY 2009 and three in FY 2008.

Inspection Classifications Listed

Clinical investigator inspections: The FDA provided the inspection classifications for 600 domestic clinical investigator inspections in FY 2019. Of the 600, 74 percent (445) were classified as no action indicated (NAI), 25 percent (152) were classified as voluntary action indicated (VAI) and 1 percent (three) were classified as official action indicated (OAI).

Of all the FY 2018 clinical investigator inspections, 72 percent were classified as NAI after 73 percent were classified NAI in FY 2017. This was the first dip in several years, as the percentage of investigator inspections classified as NAI has risen from 66 percent in FY 2016, 64 percent in FY 2015, 58 percent in FY 2014 and 56 percent classified NAI in both FY 2012 and 2013. The percentage of voluntary action indicated (VAI) classifications increased to 27 percent in FY 2018 after dropping to 26 percent in FY 2017 from 32 percent in FY 2016, 33 percent in FY 2015 and 37 percent in FY 2014 after being 42 percent in FY 2013 and 41 percent in FY 2012.

The percentage of inspections classified as official action indicated has been at 1 percent since FY 2017, after 2 percent were classified OAI in FY 2016, 3 percent in FY 2015 and 5 percent in FY 2014. OIA had been 2 percent in FY 2013 and 3 percent in FY 2012. By comparison, in FY 2011, 53 percent were classified NAI, 41 percent VAI and 6 percent OAI. In FY 2010, 46 percent of clinical investigator inspections were classified as NAI, 45 percent as VAI and 9 percent as OAI. In FY 2009, the breakdown was 48 percent NAI, 46 percent VAI and 6 percent OAI.

The FDA reported the common clinical investigator deficiencies in FY 2019 were:

  • failure to follow the investigational plan; protocol deviations;
  • failure to comply with FDA 1572 requirements;
  • inadequate and/or inaccurate case history records;
  • inadequate study records;
  • inadequate accountability for the investigational product;
  • inadequate subject protection – informed consent issues;
  • failure to report and/or record adverse events; and
  • failure to comply with 21 C.F.R. Part 56 (IRB) requirements.

Taken off the list this year was: inadequate communication with the IRB. Taken off the list in FY 2018 were: the investigational product was represented as safe/effective; and failure to follow the investigational plan/agreement and/or regulations.

IRB inspections: The percentage of IRB inspections that were classified NAI increased to 79 percent in FY 2019, up from 75 percent in FY 2018 and 77 percent in FY 2017. This is much higher than the 66 percent in FY 2016 and 59 percent in FY 2015. The percentage of inspections classified as VAI decreased to 20 percent in FY 2019 from 24 percent in FY 2018, 21 percent in FY 2017, 27 percent in FY 2016 and 37 percent in FY 2015. The percentage of IRB inspections that were classified OAI continued to be 1 percent in FY 2019 – the same as in FY 2018. The NIA percentage was 2 percent in FY 2017, 6 percent in FY 2016 and 4 percent in FY 2015.

In FY 2014, the percentages were 50 percent NAI, 37 percent VAI and 5 percent OAI. In FY 2013, it was 45 percent NAI, 49 percent VAI and 6 percent OAI. In FY 2012, the percentages were 49 percent NAI, 46 percent VAI and 5 percent OAI. In FY 2011, the percentages were 52 percent NAI, 44 percent VAI and 4 percent OAI. In FY 2010, 50 percent were classified as VAI, 44 percent NAI and 6 percent OAI. In FY 2009, half of the IRB inspections were classified as VAI, 43 percent NAI and 7 percent OAI.

The most common IRB deficiencies cited in FY 2019 were the same as those cited in past years,  with the exception of Subpart D issues, which was removed in FY 2018. The most common IRB deficiencies are:

  • failure to have minutes of IRB meetings in sufficient detail to show attendance at the meeting, vote actions and quorum issues;
  • failure to conform to membership criteria listed in 21 C.F.R. §56.107;
  • membership list;
  • failure to conduct initial and/or continuing review of research;
  • inadequate written procedures for prompt reporting of non-compliance, suspension or termination;
  • failure to prepare and maintain documentation of IRB activities; inadequate copies of research proposals and related documents.

Sponsor/monitor inspections: The percentage of domestic sponsor/monitor/CRO inspections in FY 2019 classified as NAI dipped slightly to 73 percent after increasing significantly to 75 percent in FY 2018 after being at 64 percent in FY 2017 and 65 percent in FY 2016. The percentage of sponsor/monitor inspections that were classified as NAI were 61 percent in FY 2015, 57 percent in FY 2014, 54 percent in FY 2013, 64 percent in FY 2012, and 55 percent in FY 2011.

The percentage of VAI classifications for sponsor/monitor/CRO inspections was 23 percent in FY 2019, up slightly from 22 percent in FY 2018 but well below the 30 percent in FY 2017. The percentage of inspections classified as NAI were 26 percent in 2016, 31 percent in FY 2015, 35 percent in FY 2014, 44 percent in FY 2013, 31 percent in FY 2012 and 36 percent in FY 2011. The percentage of OAI classifications increased for the first time in three years. It was 4 percent in FY 2019, 3 percent in FY 2018, 6 percent in FY 2017 and 9 percent in FY 2016. The NAI percentage was 8 percent in both FY 2014 and 2015. In FY 2013, only 2 percent of the inspections were classified as OAI. OAI was 5 percent in FY 2012 and 9 percent in FY 2011. In FY 2010, half of the sponsor/monitor inspections were NAI, 38 percent were VAI and 12 percent were OAI. In FY 2009, the percentages for sponsor/CRO inspections were 64 percent NAI, 28 percent VAI and 8 percent OAI.

The most common deficiencies were:

  • failure to select qualified investigators and/or monitors, ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan (general responsibilities of sponsors);
  • failure to maintain and/or retain adequate records in accordance with 21 C.F.R. §312.57;
  • accountability for the investigational product; and
  • failure to bring non-compliant investigators into compliance.

Sponsor-investigator inspections: For the first time, the FDA broke out sponsor-investigator inspection classifications in FY 2019. Of the 13 domestic inspections listed, 54 percent (seven) were NAI and 46 percent (six) were VAI.

The most common deficiencies were:

  • failure to submit an Investigational New Drug (IND) application;
  • failure to ensure proper monitoring of the clinical investigation;
  • failure to follow the investigational plan;
  • failure to comply with Form FDA 1572 requirements;
  • inadequate and/or inaccurate case history records;
  • inadequate study records;
  • inadequate accountability for the investigational product;
  • inadequate subject protection – informed consent issues; and
  • failure to comply with 21 C.F.R. Part 56 (IRB) requirements.

Foreign Inspection Metrics

The FDA did not include a breakdown of foreign BIMO inspections in its metrics for FY 2019.

The number of foreign BIMO inspections had increased in FY 2018 after a dip in FY 2017. There were 368 foreign BIMO inspections in FY 2018, after 359 in FY 2017, which is the same number as in FY 2015 but 30 fewer inspections than in FY 2016 when 389 foreign inspections were conducted. There were 255 foreign BIMO inspections in FY 2014, 246 in FY 2013, 254 in FY 2012 and 233 in FY 2011.

In the past, most foreign inspections were conducted by CDER (328 in FY 2018, including 167 clinical investigators, 20 sponsor/monitor/CROs, 123 BEQs, nine GLPs and nine PADE). In FY 2017 CDER conducted 323 inspections, including 143 clinical investigators, 10 sponsor/monitor/CROs, 165 BEQs and five GLPs. CDER conducted 350 foreign BIMO inspections in FY 2016, including 129 investigator, seven sponsor, 206 BEQ and eight GLP inspections in FY 2016. CDER conducted 320 foreign inspections in FY 2015, including 148 clinical investigators, 163 BEQ, six sponsor and three GLP. CDER conducted 214 foreign inspections in FY 2014, including 116 clinical investigators, 84 BEQ, 10 sponsor and four GLP. The center conducted 202 foreign inspections in FY 2013, including 102 BEQ, 98 clinical investigators and two GLP. CDER conducted 232 foreign inspections in FY 2012, including 93 BEQ inspections.

The number of foreign inspections conducted by CDRH increased in FY 2018 to 22, including 21 investigator and one sponsor/monitor/CRO inspections. In FY 2017 CDRH conducted 18 inspections, including 13 clinical investigators, four sponsor/monitor/CROs, and one GLP. In FY 2016 CDRH conducted 14 clinical investigator and two sponsor inspections. CDRH conducted 12 foreign inspections in FY 2015 and all were of clinical investigators. The Center conducted 18 in FY 2014, after doubling to 20 in FY 2013 from 10 in FY 2012. All of CDRH’s FY 2014 inspections were of clinical investigators. CDRH conducted 12 clinical investigators, six sponsor and two GLP foreign inspections in FY 2013.

The number of CBER foreign inspections dropped again in FY 2018 to 17 after 18 in FY 2017, 21 in FY 2016, and 23 in FY 2014 and 2015. All of the CBER foreign inspections dating back to FY 2014 are for clinical investigators. CBER conducted 24 inspections in FY 2013 and 10 in FY 2012. CBER conducted one foreign sponsor inspection in FY 2014 and 22 clinical investigator inspections. All of the CBER foreign inspections in FY 2012, 2013 and 2015 were of clinical investigators.

CVM reported one foreign GLP BIMO inspection in FY 2018 after conducting no foreign BIMO inspections in FY 2017. CVM conducted  two foreign GLP inspections in FY 2016 and one foreign clinical investigator inspection and one GLP inspection in FY 2015. CVM conducted no foreign inspections in FY 2013 or 2014. The center conducted two foreign sponsor inspections in FY 2012.

Overall, the FDA conducted 205 foreign clinical investigator BIMO inspections in FY 2018. The agency also conducted 123 BEQ inspections (all by CDER), 21 sponsor/monitor/CRO inspections, 10 GLP inspections and nine PADE inspections.

The FDA conducted 174 foreign clinical investigator BIMO inspections in FY 2017, 165 BEQ inspections (all by CDER), 14 sponsor/monitor/CRO inspections, and six GLP inspections. The FDA also conducted 206 BEQ inspections and 164 clinical investigator inspections in FY 2016. The agency conducted 186 clinical investigator inspections in FY 2015, 156 in FY 2014, 134 in FY 2013, 153 in FY 2012 and 121 in FY 2011 and 163 BEQ inspections in FY 2015, 84 in FY 2014, 102 in FY 2013, 93 in FY 2012 and 99 in FY 2011. There were nine sponsor inspections in FY 2016, after six in FY 2015. There were 11 in FY 2014, six each in FY 2012 and 2013 and 12 in FY 2011. There were 10 GLP inspections in FY 2016 after four each in FY 2013, 2014 and 2015 and two in FY 2012 and one in FY 2011. The FDA reported conducting 142 foreign BIMO inspections in FY 2010, of which 137 were of clinical investigators and five of sponsors.

The agency did provide the inspection classifications for foreign clinical investigator and sponsor/monitor/CRO inspections in FY 2019. Of the foreign investigator inspections classified in FY 2019, 82 percent (179) were NAI, which was the same as in FY 2018 and an increase from the 76 percent in FY 2017, 73 percent in FY 2016, and 59 percent that were NAI in FY 2015. Likewise, the percentage of VAI stayed at 18 percent (32) in both FY 2018 and 2019 compared to 24 percent in FY 2017, 26 percent in FY 2016 and 40 percent in FY 2015. There were no foreign clinical investigator inspections classified as OAI in FY 2017-2019 after there were only 0.6 percent classified as OAI in FY 2016 and 0.5 percent in FY 2015. In FY 2014, 57 percent were NAI, 40 percent VAI and 3 percent OAI. In FY 2013, 51 percent were NAI, down from 58 percent in FY 2012; 48 percent were VAI (42 percent in FY 2012); and 1 percent OAI (none in FY 2012). In FY 2011, 62 percent were NAI, 36 percent were VAI and 3 percent were OAI. In FY 2010, 45 percent were NAI, 51 percent were VAI and 4 percent were OAI.

Of the five sponsor/monitor/CRO inspections for FY 2019, 80 percent were classified as NAI and 20 percent were VAI. In FY 2018, 90 percent were classified as NAI and 10 percent were VAI. Of the 10 foreign sponsor/monitor/CRO inspections conducted by CDER in FY 2017, nine were classified as NAI and one was VAI. Of the four sponsor/monitor/CRO inspections conducted by CDRH two were NAI, one was VAI and one was OAI. Of the nine FY 2016 sponsor/CRO inspections, five were NAI, and four were VAI. Of the six sponsor/CRO inspections in FY 2015, four were NAI, one was VAI and one was OAI.

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