Gurcharan S. Syan – FDA 483, 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.
ID · 69ee4602-bc60-45f9-b4dc-082a76ac3364
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.