Joseph A. Zadra, M.D. – FDA Warning Letter, May 7, 2021

This FDA Warning Letter, Ref.: 21-HFD-45-10-01, dated October 14, 2021, was issued to Dr. Zadra following an inspection of their clinical site from May 3 to May 7, 2021. The inspection, part of FDA’s Bioresearch Monitoring Program, reviewed the conduct of clinical investigation Protocol (b)(4) for investigational drug (b)(4).

The letter states that Dr. Zadra failed to adhere to applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 312, specifically failing to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60].

Key violations include: 1. **Failure to meet inclusion criteria:** Subject (b)(4) was enrolled despite not meeting the required (b)(4) inclusion criterion, receiving study drug from (b)(4) to (b)(4). The subject's (b)(4) value was (b)(4), below the reference range of (b)(4) to (b)(4). Dr. Zadra acknowledged this, attributing it to a study coordinator error in converting (b)(4) values. 2. **Failure to perform required laboratory tests:** * For Subjects (b)(4), (b)(