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# Issues Found in BIMO Clinical Site Inspection
- URL: https://www.fdaweb.com/issues-found-in-bimo-clinical-site-inspection/
- Published: 2024-10-22T12:00:00.000Z
- Updated: 2026-09-14T14:44:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158026

An FDA 6/12-6/23/2023 Bioresearch Monitoring inspection at a clinical trial site maintained by Dr. **Namita Goyal,** an Orange, CA, neurologist, found that she violated regulations governing the proper conduct of clinical studies involving investigational products. A 10/10 Warning Letter says specific violations were:

- failure to ensure that an investigation is conducted according to the signed investigator statement, the investigation plan, and applicable regulations;
- failure to obtain legally effective informed consent before involving a human being as a subject in research under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence;
- failure to assure that an institutional review board that complies with regulatory requirements is responsible for initial and continuing review and approval of the proposed clinical study and failure to obtain IRB approval before changes in research activity; and
- failure to prepare and maintain adequate and accurate case histories.

The letter also raises two additional concerns that were not raised during the inspection. It reminds Goyal that it is the clinical investigator’s responsibility to ensure that data collected from study subjects are accurate and contemporaneous and can be relied upon in ensuring eligibility and in all analyses of the study endpoints.

Goyal was told to respond with a list of specific steps she has taken to address any violations and prevent their recurrence, with documentation showing that the matters have been addressed and a timetable for completing the corrections.