FDA 483 - Calvin Pan - October 10, 2014

An FDA inspection of Clinical Investigator Calvin Pan in Flushing, NY, revealed multiple significant deficiencies in the conduct of clinical trials. These included failures to promptly report serious adverse events to the sponsor and unanticipated problems to the IRB, as well as non-compliance with the investigational plan regarding subject eligibility and drug management. Additionally, issues were noted with informed consent for non-English speaking subjects and inadequate investigational drug disposition records.