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# FDA Bioresearch Inspection Findings Out
- URL: https://www.fdaweb.com/fda-bioresearch-inspection-findings-out/
- Published: 2023-03-08T12:00:00.000Z
- Updated: 2026-09-14T18:18:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153935

FDA has released the FY 2022 annual inspection metrics for the compliance programs within the agency’s Bioresearch Monitoring (BIMO) program. BIMO inspections (domestic and foreign) were conducted by the Office of Regulatory Affairs, except for a portion conducted by CDER subject matter experts.

According to the [metrics](https://www.fda.gov/media/165853/download?ref=fdaweb.com), the most common clinical investigator inspectional observations involved compliance with Form FDA 1572 -Statement of Investigator, failure to comply with requirements (protocol compliance), and failure to follow the investigational plan (protocol deviations). Additionally, the following observations were also some of the top cited:

- Inadequate and/or inaccurate case history records; inadequate study records
- Inadequate accountability and/or control of the investigational product
- Safety reporting; failure to report and/or record adverse events
- Inadequate subject protection; informed consent issues

Remote regulatory assessments, which replaced in-person FDA inspections during the Covid-19 pandemic, appear to be tapering off for BIMO inspection as investigators resume traditional domestic and foreign site audits. In FY 2021, FDA conducted 140 BIMO-related remote regulatory assessments, but in 2022 that number dropped by 36% to 89 assessments.

Last year, FDA released a [draft guidance](https://www.fda.gov/media/160173/download?ref=fdaweb.com), “Conducting Remote Regulatory Assessments Questions and Answers,” on how such assessments may be used post-Covid restrictions. “We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health,” the agency said at the time. “For example, when we are unable to deploy in-person staff due to travel restrictions, we may determine that a RRA is an appropriate tool. RRAs may also be used to efficiently assess establishments identified in product applications when these establishments have a prior history of compliance.”