FDA 483 - Punjwani Sohail S., MD - September 23, 2010

Punjwani Sohail S., MD, a clinical investigator in Lauderhill, FL, was cited for significant failures in conducting a clinical trial. The inspection revealed severe deficiencies in adhering to the study protocol, including improper subject enrollment, inadequate adverse event reporting to the sponsor, and widespread inaccuracies in maintaining subject case histories. Additionally, the investigator failed to promptly report an unanticipated problem to the IRB.