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  5. OII Inspectorates
  6. Office of Human and Animal Drug Inspectorate (OHADI)
  1. OII Inspectorates

Office of Human and Animal Drug Inspectorate (OHADI)

The Office of Human and Animal Drug Inspectorate (OHADI), coordinates domestic and foreign inspectional, quality, and investigational activities across the field and at headquarters. In addition, OHADI works closely with the Center for Drug Evaluation & Research (CDER) and the Center for Veterinary Medicine (CVM) on compliance and enforcement activities and to implement policies related to the Pharmaceutical program such as the Food & Drug Administration Safety & Innovation Act (FDASIA), Drug Quality & Safety Act (DQSA), Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act (GDUFA).OHADI inspections focus on: 

  • Coordinated, directs, and assists with inspections and investigations, globally, of human and animal pharmaceutical products regulated by CDER and CVM, respectively. 
  • Leads cooperative relationships with State, local, other Federal agencies, and international harmonization with other national regulatory authorities and standards setting organizations; serves on interagency councils, encourages improved State and local consumer protection programs pertinent to FDA-enforced laws and regulations related to pharmaceutical regulated by CDER and CVM. 
  • Coordinates and monitors follow-up activities related to adverse events, potential drug shortages, and emergency response activities related to pharmaceutical products regulated by CDER and CVM.

What we do

  • Domestic and foreign inspections of regulated entities manufacturing human and animal pharmaceutical products. 
  • Inspections of drug manufacturer establishments for compliance with FDA regulations.
  • Training and outreach to industry and academia
  • Collaboration with international regulatory partners

Who we are

Alonza Cruse, Office Director
Office Telephone: 240-402-2540
Email: Alonza.Cruse@fda.hhs.gov

Nancy Rolli, Deputy Office Director for Strategic Oversight
Office Telephone: 732-390-3845
Email: Nancy.Rolli@fda.hhs.gov

Contact OHADI

 

 



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