FDA 483 - Augusto D. Pichard, M.D. - February 09, 2016

An FDA inspection of Augusto D. Pichard, M.D., a clinical investigator in Washington, DC, identified two observations. The inspection found that records for device receipt were not accurate, complete, or current. Additionally, the investigation was not conducted in accordance with the signed agreement and investigational plan, specifically regarding required lab measurements and examinations for study subjects.