Carmelo Rosa PsyD U.S. FDA

Carmelo Rosa PsyD

Carmelo Rosa PsyD U.S. FDA Division Director, Office of Manufacturing and Product Quality, OC, CDER

Carmelo Rosa, Psy.D, Director Division of Drug Quality I - holds a BS/MS, and a doctoral degree as a Clinical Psychologist. He has been with the FDA for 33 years. In1990, he started as an Investigator for the Los Angeles DO. Worked for approx. 18 years as a drug Investigator, CO and member of the foreign drug inspection cadre. He conducted complex drug inspections and many criminal investigations that resulted in significant actions (e.g., WLs, Seizures, IA, CD, Prosections & Injunctions). In 2008 he transferred to the DC area. He served as a CO, TL, BC and is the Director for the Division Drug Quality I. Dr. Rosa is the former Chair of the PIC/S API Expert Circle and Professor Federal Laws enforced by FDA. He has served as a US Gov. GMP Expert Witness and CGMP trainer. He works very closely with International Regulatory Authorities. He is a frequent speaker in domestic and international conferences. Dr. Rosa is responsible for the review of inspection reports related to drug manufacturing facilities that may result in a regulatory action. On his free time he is a bass/guitar player, serves as a Licensed Psychologist, and enjoys cooking and being with his family.