FDA WARNING_LETTER - Punjwani, Sohail S., M.D. - February 18, 2009

An FDA inspection conducted between January 20 and February 18, 2009, at Professional Clinical Research, led by Dr. Sohail Punjwani, revealed significant violations in the conduct of three clinical investigations (Protocols (b)(4), (b)(4), and (b)(4)). The inspection, part of the Bioresearch Monitoring Program, found that Dr. Punjwani failed to adhere to statutory requirements and FDA regulations governing clinical investigations, specifically 21 CFR 312.60 and 21 CFR 312.66.

The primary violation was the failure to conduct studies according to investigational plans and protect subject rights, safety, and welfare. In Protocol (b)(4), six of seven randomized subjects received study drug dosages exceeding protocol-specified limits for extended periods, leading to adverse events like sedation and dizziness. Similarly, the sole subject in Protocol (b)(4) was overdosed for 17 consecutive days, resulting in worsening auditory hallucinations and self-harm. These overdoses stemmed from a misunderstanding of the study drug packaging, where different capsule strengths were not properly identified.

Additionally, Dr. Punjwani failed to develop and document dosing titration plans, assess subject compliance, and perform drug reconciliation as required by Protocols (b)(4) and (b)(4). This lack of adherence contributed to the prolonged overdosing of pediatric subjects. Furthermore, required baseline serum pregnancy and urine drug screening tests were not