FDA 483 - Endogastric Solutions, Inc. - February 29, 2012

Endogastric Solutions, Inc. in Redwood City, CA, was inspected regarding its role as a sponsor of an investigational device study. The inspection revealed significant deficiencies in study monitoring, reporting to IRBs and FDA, informed consent processes, and investigator qualifications. These issues led to protocol violations, continued subject enrollment after a study hold, and a lack of proper oversight procedures.