Karen E. D'Orazio, MS FDA

Karen D’Orazio has worked at the FDA for over 16 years.  She currently works as a Consumer Safety Officer for CDER’s Office of Compliance, Office of Manufacturing Quality (OMQ).  Mrs. D’Orazio’s responsibilities within OMQ include compliance review for advisory and judicial actions based on the regulatory significance of CGMPs; support of emerging issues and incidents to evaluate risk and product quality; and guidance to investigators during ongoing inspection.  Prior to her work with CDER Mrs. D’Orazio was a Level III Pharmaceutical Inspectorate Investigator, Field Alert Monitor, and Pre-Approval Manager for the Office of Regulatory Affairs, New Jersey District.  Mrs. D’Orazio holds a Master of Science in Public Health from the University of Massachusetts Amherst.