José E. Meléndez

Consumer Safety Officer, FDA/ORA

José E. Meléndez is an FDA Drug National Expert Investigator from ORA Office Pharmaceutical Quality Operations. Mr. Meléndez has served in several working groups related to laboratory and inspection programs since he joined FDA in 1996, details as Pre-approval manager and in the center for drugs, as well as acting manager. His positions have included San Juan District Laboratory Regulatory Program Expert and Drug Specialist Investigator since 2005. He also has 5 years of experience as a Chemist and Validation Technician for the pharmaceutical companies before joining FDA. He received his BS in Industrial Chemistry from the University of Puerto Rico. He has been a member of FDA’s Foreign Inspection Cadre since 2004, and has conducted foreign inspections of pharmaceutical manufacturers throughout Europe, Asia, Africa, Australia North and South America. Since 2010 Melendez is certified as member of FDA’s Pharmaceutical Inspectorate and continuously recertifies as Level III.