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# Over 1,000 BIMO Inspections in FY 2023
- URL: https://www.fdaweb.com/over-1-000-bimo-inspections-in-fy-2023/
- Published: 2024-08-21T12:00:00.000Z
- Updated: 2026-09-14T14:39:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Biologics, Drugs, Devices, #legacy-id-D5157626

The FDA Bioresearch Monitoring (BIMO) FY 2023 metrics [report](https://www.fda.gov/media/178661/download?attachment&ref=fdaweb.com) shows there were 1,073 BIMO inspections across the five FDA Centers. CDER had by far the largest number of inspections at 779, with 141 through CDRH, 126 through CBER, and 26 through CVM.

The report also gives common inspection observations for several categories. For clinical investigators, the common observations were:

- failing to follow the investigation plan;
- inadequate and /or inaccurate case history or study records;
- inadequate subject protection, informed consent issues;
- inadequate accountability and/or control of the investigational product; and
- safety reporting with failure to report and/or record adverse events.