Director, Division of Drug Quality I
Carmelo Rosa has a B.S., M.S., Psy.D. His background is in biology and chemistry and holds a doctoral degree as a Clinical Psychologist. He has been with FDA for over 27 years. In May 1990, he started as an Investigator for the Los Angeles district, transferred to Puerto Rico, where he worked for approximately 18 years as a pharmaceutical drug Investigator, Compliance Officer, and member of the FDA foreign drug inspection cadre. He conducted inspections of complex pharmaceutical inspections of sterile, solid dosage, and APIs, as well as other commodities regulated by FDA. He conducted many criminal investigations and inspections that resulted in a regulatory action. In 2008 he transferred to the Washington area, where since, served as Team Leader, Branch Chief, and Director for the Division Drug Quality I in the Center for Drug Evaluation and Research/Office of Compliance/Office of Manufacturing Quality. He works very closely with International Regulatory Authorities. Dr. Rosa is one of two Division Directors responsible for the review of all Official Action Indicated (OAI) inspection reports related to drug manufacturing facilities that may result in a regulatory action.