FDA 483 - Punjwani Sohail S., MD - February 18, 2009

An FDA inspection of Punjwani Sohail S., a clinical investigator in North Miami, FL, revealed significant deficiencies in the conduct of clinical trials. Observations included severe protocol deviations leading to subject overdosing, failure to perform required baseline screening tests, and critical failures in communication with the Institutional Review Board (IRB). Additionally, the firm failed to maintain adequate documentation for titration plans, dosing instructions, and staff training.