FDA WARNING_LETTER - Adarsh Daswani, M.D. - October 29, 2021

This FDA Warning Letter, dated December 20, 2022, addresses objectionable conditions observed during an FDA inspection of Dr. Daswani's clinical site from October 18 to October 29, 2021. The inspection, part of the Bioresearch Monitoring Program, reviewed the conduct of clinical investigation Protocol (b)(4) for the investigational drug (b)(4).

The primary violation cited is the failure to ensure the investigation was conducted according to the investigational plan, as required by 21 CFR 312.60. Specific deficiencies include: 1. **Failure to administer randomized treatment doses:** For subjects (b)(6), (b)(6), and (b)(6), numerous (b)(4) doses were not administered, including consecutive doses. Subject (b)(6) experienced severe (b)(4) and hospitalization. 2. **Failure to perform IRT transactions for dose adjustments:** Subjects (b)(6), (b)(6), and (b)(6) did not have required IRT transactions performed at multiple protocol-specified study visits, including consecutive ones. 3. **Failure to follow protocol for HemoCue Hgb ≥12 g/dL:** For Subject (b)(6), randomized treatment was not held when HemoCue Hgb was ≥12 g/dL, and subsequent dose adjustments were not made according to protocol.

Dr.