Former Director of Compliance (FDA)
Howard Manresa is an expert in Food and Drug Administration (FDA) regulatory compliance. Prior to becoming a private consultant, he spent more than 30 years working for the FDA.
Mr. Manresa is the former Director of the Compliance Branch of the FDA’s Denver District Office, where he supervised the compliance officers, recall coordinators, Legal Administrative Specialists (Freedom of Information specialists), and Consumer Safety Technicians.
During his 14 years as an FDA Compliance Director, Mr. Manresa coordinated regulatory activities related to untitled letters, regulatory meetings, warning letters, seizures, injunctions, civil money penalties, and criminal prosecutions. He was also responsible for submitting proposals for regulatory action to the Office of Compliance for the Centers, the Office of Enforcement and Import Operations, the FDA’s Office of the Chief Counsel, and the U. S. Department of Justice. Mr. Manresa additionally reviewed evidence collected from the Investigations and Laboratory Branches and formulated informal and legal strategies for bringing non-compliant firms into lasting compliance.
Prior to becoming a Compliance Director, Mr. Manresa served as an FDA Compliance Officer in the Minneapolis District Office. As a Compliance Officer, he specialized in the areas of drugs, biologics, and health fraud, and he served on the Medical Device Team.
Mr. Manresa is a graduate of the FDA Leadership Development Program. He received his Bachelor of Arts degree in Organismic Biology and his Bachelor of Science degree in Medical Technology from the University of Colorado. Mr. Manresa is also a certified Medical Technologist and a Histologic Technician with the American Society of Clinical Pathologists.