Denise DiGiulio, is a compliance officer in the Office of Manufacturing & Product Quality in CDER. She has been with FDA for 14 years. She began her service with FDA at the Philadelphia and New Jersey District Offices as an investigator and performed primarily drug manufacturing inspections, both domestic and international. In 2009, she transferred to her current position as a compliance officer in the Division of Good Manufacturing Practice Assessment (DGMPA). DiGiulio’s main responsibility in DGMPA includes reviewing and evaluating pre-approval inspection reports and recommendations from district offices to provide a site acceptability decision to other CDER offices. She continues to be a lead investigator for drug manufacturing CGMP pre-approval and surveillance inspections. She is an officer in the United States Public Health Service. DiGiulio received her BS in pharmacy from Rutgers College of Pharmacy and is a registered Pharmacist in New Jersey.