FDA 483 - Robert D. Ferrera, MD - May 22, 2008

An FDA inspection of Ferrera, R. David, MD in Sacramento, CA, a clinical investigator, revealed significant issues with the conduct of a clinical investigation. The firm failed to follow the signed statement of investigator, specifically regarding incorrect drug kit dispensation and the failure to report an adverse event for a study subject. These observations indicate a lack of adherence to proper clinical trial procedures.