# FDA WARNING_LETTER - Bay Regional Medical Center IRB - June 24, 2011

Source: https://www.keypedia.com/records/warning_letter/bay-regional-medical-center-irb/d80b0a40-b39b-4d68-9434-8177e4f61a4e

> FDA WARNING_LETTER for Bay Regional Medical Center IRB on June 24, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bay Regional Medical Center IRB
- Inspection Date: 2011-06-24
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to McLaren Health Care regarding its Institutional Review Board (IRB) at Bay Regional Medical Center (BRMC) following a June 2011 inspection. The inspection revealed the IRB failed to comply with 21 CFR parts 50 and 56, concerning the protection of human subjects.

Key violations include:
1.  **Improper Expedited Review Procedures [21 CFR 56.110(b)]**: The IRB used expedited review for studies that were still open for subject accrual and had enrolled subjects, which should have undergone full board review. BRMC's proposed corrective actions (SOP modification, training) were deemed inadequate as they lacked administrative review or tools to ensure appropriate expedited review use.
2.  **Failure to Conduct Annual Continuing Review and Follow Procedures [21 CFR 56.109(f), 56.108(a)]**: The IRB failed to conduct continuing review of research at least annually, as required by regulations and its own written procedures. This is a repeat violation from a September 2010 Warning Letter, indicating inadequate implementation of previous corrective actions.
3.  **Inadequate Documentation of IRB Activities [21 CFR 56.115(a)(2)]**: The IRB maintained conflicting and inaccurate meeting minutes, with discrepancies in attendance, vote counts, and IRB member roles, making it difficult to verify quorum.

## Related Documents

- [WARNING_LETTER - 2010-06-04](https://www.keypedia.com/records/warning_letter/bay-regional-medical-center-irb/8119ef03-3a89-4edb-9c14-3f8e750e2715)

## Related Officers

- [Jay L. Summer](https://www.keypedia.com/people/jay-l-summer/0994ef99-bbea-48cf-96b9-a1012b1b36fe)
- [J.](https://www.keypedia.com/people/ian-gray/331443fc-8143-474e-aeda-15269a799ac8)
- [Ashir Kumar](https://www.keypedia.com/people/ashir-kumar/7aa0581f-f5fb-48b8-99f8-f84ed667af5a)
- [Leslie K. Ball](https://www.keypedia.com/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)
- [Mohammed Al-Qasmi](https://www.keypedia.com/people/mohammed-al-qasmi/8324cc78-bb12-4cc0-b74d-35a8e8585f44)

Company: https://www.keypedia.com/companies/bay-regional-medical-center-irb/6bbecaf2-3243-44d9-ae6c-a613d5d65d86

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c