Carmelo Rosa

Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Dr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and during 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. He was the Lead FDA Investigator in high profile cases for the FDA that resulted in criminal indictments, and guilty pleas by defendants. While in San Juan he worked very closely with the Office of Criminal Investigations (OCI). In August 2008 relocated to Maryland to work for CDER as Compliance Officer. He was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He was subsequently promoted to Director for the Division of International Drug Quality. Dr. Rosa is also an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives, and is also responsible for the evaluation of all GMP inspection reports of foreign pharmaceutical manufacturers and testing facilities. He is also one of FDA's representatives at PIC/S.