# FDA WARNING_LETTER - Mehran Michael Bahrami, M.D. - April 19, 2024

Source: https://www.keypedia.com/records/warning_letter/mehran-michael-bahrami-md/ca994571-2a72-4768-b457-48a0cda28db7

> FDA WARNING_LETTER for Mehran Michael Bahrami, M.D. on April 19, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mehran Michael Bahrami, M.D.
- Inspection Date: 2024-04-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Dr. Bahrami following an inspection from April 8-19, 2024, under the Bioresearch Monitoring Program, which revealed objectionable conditions in the conduct of clinical investigations for Protocols (b)(4) and (b)(4). The inspection found non-adherence to the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312.

Key violations include:
1.  **Failure to conduct investigations according to the investigational plan (21 CFR 312.60):**
    *   **Protocol (b)(4):** Subject (b)(6) was enrolled despite exceeding the protocol-required symptom onset and sample collection timeframes for (b)(4) infection.
    *   **Protocol (b)(4):** Subjects (b)(6) and (b)(6) were enrolled despite being current/former smokers, a high-risk exclusion criterion.
    *   **Protocol (b)(4):** Subjects (b)(6), (b)(6), and (b)(6) had virtual visits for Days 3, 5, 10, and 15 instead of required in-person visits, leading to missed vital signs, physical examinations, and safety laboratory assessments.
2.  **Failure to retain required records (21 CFR 312.62(c)):** Electronic case report forms

## Related Officers

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Company: https://www.keypedia.com/companies/mehran-michael-bahrami-md/433e8447-9f6d-46e2-b72e-4b3051dbe610

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