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. Author manuscript; available in PMC: 2021 Sep 1.
Published in final edited form as: Ther Innov Regul Sci. 2020 Feb 24;54(5):1123–1133. doi: 10.1007/s43441-020-00129-z

Table 10.

Clinical Investigator Inspections.

Classification FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 Total
NAI 52% (308) 50% (353) 48% (416) 46% (340) 53% (324) 56% (320) 56% (372) 58% (466) 64% (526) 66% (512) 73% (512) 4449 (57%)
VAI 40% (237) 41% (289) 46% (399) 45% (333) 41% (251) 41% (235) 42% (279) 37% (297) 33% (271) 32% (248) 26% (182) 3021 (38%)
OAI 8% (47) 9% (63) 6% (52) 9% (66) 6% (36) 3% (17) 2% (13) 5% (40) 3% (25) 2% (15) 1% (7) 381 (5%)
Total 592 705 867 739 611 572 664 803 822 775 701 7851
Warning Letters 26 28 25 23 13 9 9 13 6 6 3 161