FDA 483 - Gurcharan S. Syan - May 30, 2014

An FDA inspection of Clinical Investigator Gurcharan S. Syan revealed significant deficiencies in the conduct of clinical trials. Observations included failures in obtaining timely informed consent for protocol revisions, numerous deviations from investigational plans regarding subject eligibility and medication administration, and inadequate record-keeping for investigational product accountability and storage conditions. These issues indicate a concerning lack of adherence to clinical trial regulations and protocols.