FDA WARNING_LETTER - Mobeen Mazhar, M.D. - April 28, 2022

This FDA Warning Letter, dated May 31, 2023, addresses Dr. Mazhar regarding objectionable conditions observed during an FDA inspection of their clinical site between March 22 and April 28, 2022. The inspection, part of the Bioresearch Monitoring Program, evaluated the conduct of clinical investigations, specifically Protocol (b)(4), and the protection of human subjects.

The letter identifies two primary violations: 1. **Failure to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]:** * **Enrollment of ineligible subjects:** Subjects were enrolled despite not meeting required blood pressure (DBP ≥ 100 mm Hg) and prescreening laboratory criteria (PRA ≤ 0.6 ng/mL and serum aldosterone ≥ 6 ng/dL). For example, Subject (b)(6) with DBP 110.5 mm Hg and Subject (b)(6) with DBP 100 mm Hg were randomized. Subject (b)(6) with serum aldosterone < 1 ng/dL and Subject (b)(6) with serum aldosterone 3 ng/dL underwent screening or received study drug. * **Failure to report Adverse Events of Special Interest (AESI) within 24 hours:** Hyperkalemia (serum potassium > 5.2 mEq/L) for Subject (b