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

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