# FDA WARNING_LETTER - West Jefferson Medical Center IRB - July 26, 2007

Source: https://www.globalkeysolutions.net/records/warning_letter/west-jefferson-medical-center-irb/81d2b7e9-7792-4b61-902a-4b096c6e41df

> FDA WARNING_LETTER for West Jefferson Medical Center IRB on July 26, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: West Jefferson Medical Center IRB
- Inspection Date: 2007-07-26
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected West Jefferson Medical Center's IRB from July 23-26, 2007, to assess compliance with 21 CFR Parts 50 and 56 regarding human subject protection in clinical studies. The inspection revealed significant deficiencies.

Violations included:
1.  **Conflict of Interest:** An IRB member participated in the initial review and vote of their own study without being excused (21 CFR 56.107(e)).
2.  **Inadequate Written Procedures:** The IRB lacked written procedures for determining significant risk (SR) or non-significant risk (NSR) for device studies, as required by 21 CFR 56.115(a)(6), 56.108(a)(1), and 812.66.
3.  **Failure to Follow Continuing Review Procedures:**
    *   Written procedures did not reflect actual practice, leading to studies expiring before continuing review (21 CFR 56.108(a)(1)).
    *   The IRB failed to follow up with investigators who did not submit required progress reports by deadlines.
4.  **Improper Meeting Quorum/Composition:** Several meetings lacked a majority of members and/or a nonscientific member, as required for non-expedited reviews (21 CFR 56.108(c)).
5.  **Failure

## Related Officers

- [Leslie K. Ball](https://www.globalkeysolutions.net/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)

Company: https://www.globalkeysolutions.net/companies/west-jefferson-medical-center-irb/49ed7473-89c1-4590-bd9a-6069ef15169a

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