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# Common BIMO Violations Listed
- URL: https://www.fdaweb.com/common-bimo-violations-listed/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:20.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5157425

Attorney **Julie Tibbets** (Goodwin) has identified the two most common bioresearch monitoring (BIMO) violations shown in FY 2023 Warning Letters to clinical investigators. She [says](https://www.goodwinlaw.com/en/insights/publications/2024/07/alerts-lifesciences-common-fda-bioresearch-monitoring-violations?ref=fdaweb.com) the most common violations were:

- failure to ensure that the investigation was conducted according to the investigational plan; and
- failure to submit an IND application for the conduct of a clinical investigation with an investigational new drug.

She notes that FDA conducted 1,073 BIMO inspections in FY 2023, with about 79% of them involving drug, biologic, or medical device clinical investigators, institutional review boards (IRBs), sponsors, clinical research organizations, and sponsor-investigators.

To date in 2024, Tibbets writes, there have been six Warning Letters issued to clinical investigators, sponsors, and IRBs, with four of them involving failure to conduct an investigation according to the investigational plan. She says that four Warning Letters have related to IRB activities, including failure to ensure the informed consent form complied with regulations, failure to ensure ongoing IRB review and approval of a study, failure to ensure IRB written procedures for prompt reporting of unanticipated problems to the IRB, and failure to ensure prospective IRB review of continued use of an investigational drug beyond two initial doses authorized for emergency access.